FDA Adverse Event
Malfunction
Summary report: N
MANUAL FILL INFANT HUMIDIFICATION CHAMBER
MDR report key: 1200104
·
Received October 15, 2008
Report
- Report Number
- 9611451-2008-00605
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Report Date
- September 16, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- PMA / PMN Number
- K913367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. NO RESULTS AND CONCLUSIONS ARE THEREFORE AVAILABLE AT PRESENT. A FOLLOW-UP REPORT WILL BE PREPARED AND FORWARDED AS SOON AS THE DEVICE HAS BEEN RETURNED AND INVESTIGATION RESULTS BECOME AVAILABLE. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER.
Description of Event or Problem · 1
A HOSPITAL REPORTED THAT A MR225 MANUAL FILL INFANT/PEDIATRIC HUMIDIFICATION CHAMBER CRACKED AS A RESULT OF BACK PRESSURE FROM THE OSCILLATOR IT WAS CONNECTED TO. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL FILL INFANT HUMIDIFICATION CHAMBER | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | MR225X | 070524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |