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7.11.4 PSH - product summary header segment

Figure 7-23. PSH attributes

SEQ

LEN

DT

OPT

RP/ #

TBL #

ITEM #

ELEMENT NAME

1

60

ST

R



01233

Report Type

2

60

ST

O



01234

Report Form Identifier

3

26

TS

R



01235

Report Date

4

26

TS

O



01236

Report Interval Start Date

5

26

TS

O



01237

Report Interval End Date

6

12

CQ

O



01238

Quantity Manufactured

7

12

CQ

O



01239

Quantity Distributed

8

1

ID

O


0329

01240

Quantity Distributed Method

9

600

FT

O



01241

Quantity Distributed Comment

10

12

CQ

O



01242

Quantity in Use

11

1

ID

O


0329

01243

Quantity in Use Method

12

600

FT

O



01244

Quantity in Use Comment

13

2

NM

O

Y/8


01245

Number of Product Experience Reports Filed by Facility

14

2

NM

O

Y/8


01246

Number of Product Experience Reports Filed by Distributor

7.11.4.0 PSH field definitions

7.11.4.1 Report type (ST) 01233

Definition: This field contains the name, title, or other description of the report. Typically, the field will include the agency name (e.g., FDA), agency component if applicable (e.g., CDRH) and the report type (e.g., Medical Device Reporting Baseline Report).

7.11.4.2 Report form identifier (ST) 01234

Definition: This field contains the form descriptor which describes the report. Typically, the field will include the agency name (e.g., FDA), agency component if applicable (e.g., CDRH) and the form number (e.g., 3417).

7.11.4.3 Report date (TS) 01235

Definition: This field contains the date as assigned by the sender.

7.11.4.4 Report interval start date (TS) 01236

Definition: This field contains the date which marks the beginning of the time interval covered by the current report.

7.11.4.5 Report interval end date (TS) 01237

Definition: This field contains the date which marks the inclusive end of the time interval covered by the current report.

7.11.4.6 Quantity Manufactured (CQ) 01238

Components: <quantity> ^ <units>

Definition: This field is used to send the number of units of the product manufactured during the reporting interval. The second component can be used to specify the units for the quantity.

7.11.4.7 Quantity Distributed (CQ) 01239

Components: <quantity> ^ <units>

Definition: This field is used to send the number of units of the product which were distributed during the reporting interval. The second component can be used to specify the units for the quantity.

7.11.4.8 Quantity distributed method (ID) 01240

Definition: This field is used for measuring the quantity distributed. An explanation of the method used for estimation can be included in PSH-9-quantity distributed comment. Refer to HL7 table 0329 - Quantity method for valid values.

Table 0329 - Quantity method

Value

Description

A

Actual count

E

Estimated (see comment_

7.11.4.9 Quantity Distributed Comment (FT) 01241

Definition: This field is used for any explanatory text needed but in particular should provide a description of the estimation method used. If referring to the description used in a previous report, the comment should include the product identifier and data of that report.

7.11.4.10 Quantity in use (CQ) 01242

Components: <quantity> ^ <units>

Definition: This field is used to send the number of units of the product which were in use during the reporting interval. The second component can be used to specify the units for the quantity.

7.11.4.11 Quantity in use method (ID) 01243

Definition: This field contains the method used for measuring the quantity in use. An explanation of the method used for estimation can be included in PSH-12-quantity in use comment. Refer to HL7 table 0329 - Quantity method for valid values.

7.11.4.12 Quantity in use comment (FT) 01244

Definition: This field can be used for any explanatory text needed but in particular should provide a description of the estimation method used. If referring to the description used in a previous report, the comment should include the product identifier and data of the report.

7.11.4.13 Number of product experience reports filed by facility (NM) 01245

Definition: The field contains the number of product experience reports filed by facility.

7.11.4.14 Number of product experience reports filed by distributor (NM) 01246

Definition: This field contains the number of product experience reports filed by distributor.

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