MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-28 for MANUAL CONTROLLED COSYCOT INFANT WARMER IW950 manufactured by Fisher & Paykel Healthcare Ltd.
[187427461]
(b)(4). Method: the complaint iw950 manual controlled cosycot infant warmer was evaluated by a trained f&p service technician at our service centre in (b)(4). Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power. The root cause was identified to be the failure of a capacitor on the pcb board. Conclusion: it is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is more than 15 years old. The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power. Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution. The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks including the power fail alarm at least once a year. Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications. The reported malfunction was discovered during a maintenance check with no patient involvement.
Patient Sequence No: 1, Text Type: N, H10
[187427462]
A healthcare facility in (b)(6) requested a routine servicing for iw950 manual controlled cosycot infant warmer. During servicing, a fisher & paykel healthcare (f&p) service engineer observed that the power fail alarm was not working. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00305 |
| MDR Report Key | 9892459 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-28 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2004-02-27 |
| Date Added to Maude | 2020-03-28 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4534000142 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL CONTROLLED COSYCOT INFANT WARMER |
| Generic Name | FMT |
| Product Code | FMT |
| Date Received | 2020-03-28 |
| Model Number | IW950 |
| Catalog Number | IW950 |
| Lot Number | 040227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |