MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for GAS SUPPLY MODULE 900IW104 manufactured by Fisher & Paykel Healthcare Ltd.
[123956991]
(b)(4). The 900iw104 gas supply module is an accessory that can be supplied with the iw932 cosycot infant warmer. The 900iw104 gas supply module is not sold in the usa, but it is similar to the 900iw101 gas supply module, which is sold in the usa. Sms technologies (uk) is the manufacturer of the oxygen/air gas supply module (sms technologies part number fp900iw104s). Sms technologies has ceased trading, thus they could not be notified of this complaint. Method: the complaint 900iw104 gas supply module was not returned to fisher & paykel healthcare in (b)(4) for investigation. Our investigation is thus based on the information provided by the customer. Results: the customer informed us that the air regulator on the subject gas supply module was leaking air when turned on. The customer stated that the air regulator on the subject gas supply module was replaced with a new air regulator and the issue was resolved. Conclusion: we are unable to determine what caused the leak in the gas supply module as reported by the customer, however based on the information provided, it was likely caused by a faulty air regulator.
Patient Sequence No: 1, Text Type: N, H10
[123956992]
A hospital in (b)(6) reported via a fisher & paykel healthcare representative that clinical staff needed to use the resuscitation module on the iw932 cosycot infant warmer during an emergency, however gas was found leaking from the 900iw104 gas supply module and therefore it was unable to be used. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2018-00856 |
| MDR Report Key | 7958979 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-14 |
| Date Mfgr Received | 2018-09-14 |
| Date Added to Maude | 2018-10-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | GAS SUPPLY MODULE |
| Generic Name | BYX |
| Product Code | BYX |
| Date Received | 2018-10-11 |
| Returned To Mfg | 2018-11-06 |
| Model Number | 900IW104 |
| Catalog Number | 900IW104 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-11 |