FDA Adverse Event
Malfunction
Summary report: N
BZE
MDR report key: 951766
·
Received November 26, 2007
Report
- Report Number
- 9611451-2007-00462
- Event Type
- Malfunction
- Date Received
- November 26, 2007
- Report Date
- October 23, 2007
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BZE
- PMA / PMN Number
- K034026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING THE RETURN OF THE COMPLAINT DEVICE TO COMPLETE OUR INVESTIGATION. AN INITIAL EVALUATION WAS DONE ON A SUPPLIED PHOTOGRAPHIC IMAGE. RESULTS: OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE FOR THE GIVEN LOT NUMBER. A SMALL INDENT WAS NOTED ON THE SUCTION PORT OF THE SWIVEL Y-PIECE; HOWEVER, IT WAS DIFFICULT TO DETERMINE IF THERE WAS A HOLE. CONCLUSIONS: NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
A HOSPITAL REPORTED THAT A RT236 INFANT EVAQUA BREATHING CIRCUIT FAILED THE INITIAL LEAK TEST ON A SERVO I VENTILATOR. A SMALL HOLE WAS ALLEGEDLY FOUND ON A PORT OF THE Y-PIECE. THE DEVICE WAS NOT ON A PATIENT AT THE TIME OF THE ALLEGED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BZE | BZE | FISHER & PAYKEL HEALTHCARE, LTD. | RT236 | 070903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |