FDA Adverse Event
Malfunction
Summary report: N
ZIMMER PULSAVAC PLUS FAN SPRAY KIT
MDR report key: 2191457
·
Received June 16, 2011
Report
- Report Number
- 1526350-2011-00123
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 19, 2011
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- FQH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, THE BATTERY LIQUID DRIPPED TO THE OUTSIDE OF THE BATTERY PACK AND ADHERED ON THE INSTRUMENT TABLE. BUT THE PT, SURGEON AND THE NURSES AT THAT SURGERY WERE NOT AFFECTED BY THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER PULSAVAC PLUS FAN SPRAY KIT | FAN SPRAY KIT | FQH | ZIMMER SURGICAL | NA | 61640712/61650755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |