FDA Adverse Event
Malfunction
Summary report: N
AUTOFEED HUMIDIFICATION CHAMBER
MDR report key: 2032956
·
Received March 29, 2011
Report
- Report Number
- 9611451-2011-00204
- Event Type
- Malfunction
- Date Received
- March 29, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 28, 2011
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD
- Product Code
- BTT
- PMA / PMN Number
- K934140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 1
A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS WATER LEAKAGE AT THE CONNECTION OF THE BAG SPIKE AND WATER FEEDSET TUBE OF AN MR290UX AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.
Description of Event or Problem · 1
A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THERE WAS WATER LEAKAGE AT THE CONNECTION OF THE BAG SPIKE AND WATER FEEDSET TUBE OF AN MR290UX AUTOFEED HUMIDIFICATION CHAMBER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOFEED HUMIDIFICATION CHAMBER | BTT | BTT | FISHER & PAYKEL HEALTHCARE LTD | MR290UX | 100216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |