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

Model Number IW990

Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative, that the power fail alarm of an iw990 wall mount infant warmer was not working.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint iw990 infant warmer was returned to the fisher & paykel healthcare (f&p) regional office in germany where it was performance tested by a trained f&p service technician.Our investigation is thus based on the information provided by the f&p service technician.Results: performance testing of the iw990 infant warmer revealed that the unit's power fail alarm did not function.The unit was found to have a faulty capacitor.Conclusion: the reported event was due to a faulty capacitor on the power pcb.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 germany reported via a fisher & paykel healthcare field representative, that the power fail alarm of an iw990 wall mount infant warmer was not working.There was no reported patient involvement.

• 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: 12311275
• MDR Text Key: 267833151
• Report Number: 9611451-2021-00930
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 150218
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1