FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 SP NEW
MDR report key: 2182749
·
Received July 11, 2011
Report
- Report Number
- 2921482-2011-00091
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 9, 2011
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THIS WAS DUE TO A BROKEN BOTTOM PRINTED CIRCUIT BOARD. THE CAUSE OF THE BROKEN BOTTOM PWA COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEMSTAR 7 SP NEW | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |