MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD GAS SUPPLY MODULE; BYX

Model Number 900IW104

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

Event Description

A hospital in ireland 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.

Manufacturer Narrative

(b)(4).The 900iw104 gas supply module is an accessory that can be supplied with the iw932 cosycot infant warmer.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.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.The customer confirmed that the air regulator component of the complaint 900iw104 gas supply module was replaced.It was confirmed that there was no further leak after replacement of the air regulator.Method: the air regulator component of the 900iw104 was leak tested at our regional facility in the uk by a trained service technician.The air regulator was then returned to fisher & paykel healthcare in new zealand where it was additionally visually inspected.Results: there were no physical defects noted with the returned air regulator, however leak testing confirmed that the device was leaking.Conclusion: we are unable to determine what may have caused the reported incident.

• Brand Name: GAS SUPPLY MODULE
• Type of Device: BYX
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7958979
• MDR Text Key: 123956991
• Report Number: 9611451-2018-00856
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900IW104
• Device Catalogue Number: 900IW104
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P IW932 COSYCOT INFANT WARMER; F&P IW932 COSYCOT INFANT WARMER