MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07 report with the FDA on 2007-01-17 for 900MR510 REUSABLE HEATER WIRE manufactured by Fisher & Paykel Healthcare, Ltd..
[604786]
The hosp reported that they have had 15 reusable heater wire assemblies that have cracked at the v-notch on the elbow connector. (note the v-notch is part of the connection port where a temperature / flow probe is inserted).
Patient Sequence No: 1, Text Type: D, B5
[7925152]
No information to date. Investigation still underway, no results to date. No conclusion can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2007-00005 |
| MDR Report Key | 809012 |
| Report Source | 00,01,06,07 |
| Date Received | 2007-01-17 |
| Date of Report | 2006-12-18 |
| Date Mfgr Received | 2006-12-18 |
| Date Added to Maude | 2007-01-29 |
| 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 | RENETA MONEY, ENGINEER |
| 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 | 900MR510 REUSABLE HEATER WIRE |
| Generic Name | * |
| Product Code | HCS |
| Date Received | 2007-01-17 |
| Model Number | 900MR510 |
| Catalog Number | 900MR510 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 796509 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | * AUCKLAND NZ |
| Baseline Brand Name | 900MR510 REUSABLE HEATER WIRE |
| Baseline Generic Name | * |
| Baseline Model No | 900MR510 |
| Baseline Catalog No | 900MR510 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-17 |