MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL CONTROLLED INFANT WARMER; FMT

Model Number IW990

Device Problems No Audible Alarm (1019); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw990 wall mount infant warmer is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported that the iw990 wall mount infant warmer speaker was not working.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the pcb assay control manual of the complaint iw990 wall mount infant warmer was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and performance tested.Results: performance testing of the iw990 wall mount infant warmer revealed that the unit's power fail alarm did not function.The fault was traced to the failure of a component on the pcb.Conclusion: we are unable to determine the cause of the reported event.The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution.The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks including the power fail alarm at least once a year.Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.The subject infant warmer was repaired and was returned to the customer after passing all the required safety and performance tests.

Event Description

A healthcare facility in the uk reported that the iw990 wall mount infant warmer speaker was not working.There was no reported patient consequence.

• Brand Name: MANUAL CONTROLLED INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11024797
• MDR Text Key: 222300299
• Report Number: 9611451-2020-01169
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990
• Device Catalogue Number: IW990
• Device Lot Number: 120221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1