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

Model Number 900IW104

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 900iw104 gas supply module is an accessory that can be supplied with the iw952 cosycot infant warmer.Sms technologies is the manufacturer of 900iw104 oxygen/air gas supply module whom have ceased trading in 2017, 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.Method: the 900iw104 gas supply module was received at our fisher & paykel (f&p) regional office in the (b)(6) and was inspected by a trained f&p service technician.Results: during testing, it was found that the gas manifold cylinder bodok seal was missing.The device was repaired, performance tested and returned to the customer.Conclusion: we are unable to determine the cause of the reported event.However, the reported leakage for this incident is most likely due to the missing bodok seal on gas manifold.

Event Description

A healthcare facility in the (b)(6) reported of a gas leakage on a 900iw104 gas supply module.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 92618 ; 9494534000
• MDR Report Key: 11128323
• MDR Text Key: 241665111
• Report Number: 9611451-2021-00004
• 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: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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?: Yes
• Date Manufacturer Received: 12/09/2020
• 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