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

Model Number 900IW103

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 900iw103 gas supply module is an accessory that can be supplied with the iw930 cosycot infant warmer.Bpr medical gas control is the manufacturer of the oxygen/air gas supply module (bpr medical gas control part number 900iw103).Bpr medical gas control has resumed trading from sms technologies whom have ceased trading, thus they could not be notified of this complaint.The 900iw103 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.Method: the 900iw103 gas supply module was received at our fisher & paykel (f&p) service center in the (b)(6) and was inspected by a trained f&p service technician.The shuttle valve component in the manifold of the 900iw103 was leak tested.Results: during testing, it was found that the oxygen manifold was not holding pressure when the oxygen tank was disconnected.This was due to the leaky shuttle valve component, however replacement of the shuttle valve component resolved the issue.Conclusion: we are unable to determine what may have caused the reported incident.

Event Description

A healthcare facility in the (b)(6) requested a routine service for a 900iw103 gas supply module.During device assessment on the (b)(6) 2020 at the fisher & paykel healthcare (f&p) regional office in the (b)(6), it was found that the oxygen manifold of the 900iw103 gas supply module had a leaky valve.There was no patient involvement.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, ca ; 4534000142
• MDR Report Key: 9955753
• MDR Text Key: 198183590
• Report Number: 9611451-2020-00273
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900IW103
• Device Catalogue Number: 900IW103
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1