MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2007-02-21 for REUSABLE HEATER WIRE 900MR510 * manufactured by Fisher & Paykel Healthcare Ltd..
[558241]
A hospital in another country reported that the plastic part of the 900mr510 heater wire assembly was damaged and broken. According to the hospital, the cleaning of the 900mr510 heater wire at 75 degree celsius and subsequent sterilization, at 55 degree celsius using ethylene oxide gas sterilizing could have been a contributory cause.
Patient Sequence No: 1, Text Type: D, B5
[7924937]
Conclusions: no conclusion can be made at this time. The device is reusable; however, we do not know whether the problem was discovered in use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00036 |
| MDR Report Key | 837443 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2007-02-21 |
| Date of Report | 2007-01-19 |
| Date Mfgr Received | 2007-01-24 |
| Date Added to Maude | 2007-04-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | IVY CHENG |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE PO BOX 14348, EAST TAMAKI |
| Manufacturer City | PANMURE, AUCKLAND 1741 |
| Manufacturer Country | NZ |
| Manufacturer Postal | 1741 |
| Manufacturer Phone | 5740100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE HEATER WIRE |
| Generic Name | * |
| Product Code | HCS |
| Date Received | 2007-02-21 |
| Returned To Mfg | 2007-01-24 |
| Model Number | 900MR510 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 824752 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD. |
| Manufacturer Address | * AUCKLAND NZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-21 |