MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-20 for COSYCOT INFANT WARMER IW934 manufactured by Fisher & Paykel Healthcare Ltd.
[131806051]
(b)(4). Method: the complaint infant warmer was not returned to fisher & paykel healthcare (f&p) (b)(4) for investigation. Our analysis thus based on the information and photogrph provided by the customer, previous investigations and our knowledge of the product. Results: visual inspection of the provided photograph revealed that the connectors on the head harnesses were discolored. Conclusion: the upper and lower harnesses are used to connect the head unit to the control unit of the infant warmer. Previous investigations of similar complaints revealed that the discoloration was most likely due to poor electrical contact caused by the degradation of the harness connectors. This degradation is likely a result of swivelling of the warmer head. The subject infant warmer is over 14 years old and a reasonable level of wear and tear is expected. All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul). The entire harness is enclosed in a ul v-0 rated fire retardant enclosure. Should the connectors completely fail during the operation, an audible and visual alarm will be registered on the front control panel of the infant warmer, thereby allowing the hospital staff time to act and provide other means of warming. The infant warmer technical/service manual also contains a checklist which specifies that users perform safety, performance, and functional checks at least once a year.
Patient Sequence No: 1, Text Type: N, H10
[131806052]
A healthcare facility in (b)(6) reported that an iw934 cosycot infant warmer displayed an error e17. The clinical engineer at the healthcare facility confirmed that the harness connector was found to be discolored. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-01105 |
| MDR Report Key | 8188109 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-21 |
| Date Mfgr Received | 2018-11-21 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Manufacturer Contact | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| 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 | COSYCOT INFANT WARMER |
| Generic Name | FMT |
| Product Code | FMT |
| Date Received | 2018-12-20 |
| Model Number | IW934 |
| Catalog Number | IW934 |
| Lot Number | 041001 |
| 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 | 2018-12-20 |