FDA Adverse Event
Malfunction
Summary report: N
NEOPUFF INFANT RESUSCITATOR
MDR report key: 2123220
·
Received August 4, 2008
Report
- Report Number
- 9611451-2008-00472
- Event Type
- Malfunction
- Date Received
- August 4, 2008
- Report Date
- May 5, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTL
- PMA / PMN Number
- K892885
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLEASE ALSO REFERENCE MDR # 9611451-2008-00333, 9611451-2008-00471 AND 9611451-2008-00473. THE COMPLAINT DEVICE IS CURRENTLY BEING INVESTIGATED. A F/U REPORT WILL BE PROVIDED ONCE WE RECEIVE THE INVESTIGATION REPORT.
Description of Event or Problem · 1
A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT UPON OPENING THE BOXES OF THE FOUR (B)(4) NEOPUFF INFANT RESUSCITATORS, FROSTY MANOMETERS WERE FOUND. THE NUMBERS IN THE MANOMETERS CANNOT BE SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOPUFF INFANT RESUSCITATOR | BTL | FISHER & PAYKEL HEALTHCARE, LTD. | RD900AEU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |