FDA Adverse Event
Malfunction
Summary report: N
REUSABLE ADULT CIRCUIT TUBING
MDR report key: 1841450
·
Received September 15, 2010
Report
- Report Number
- 9611451-2010-00552
- Event Type
- Malfunction
- Date Received
- September 15, 2010
- Report Date
- August 19, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BZO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADD'L LOT NUMBERS & DEVICE MANUFACTURE DATES: 100401, 04/01/10; 100415, 04/15/10; 100517, 05/17/10. THE 900MR067 REUSABLE ADULT CIRCUIT TUBINGS ARE EN ROUTE TO FPH FOR INVESTIGATION. WE WILL PROVIDE A F/U REPORT ONCE WE RECEIVE THE COMPLAINT DEVICES AND HAVE COMPLETED OUR INVESTIGATION.
Description of Event or Problem · 1
A DISTRIBUTOR IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REP THAT HOLES WERE OBSERVED IN A QUANTITY OF 400 900MR067 REUSABLE ADULT CIRCUIT TUBINGS. THIS WAS NOTICED DURING THEIR FUNCTIONAL TESTING PROCESS. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REUSABLE ADULT CIRCUIT TUBING | BZO | FISHER & PAYKEL HEALTHCARE, LTD. | 900MR067 | 100316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |