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 regarding the complaint iw990 wall mount infant warmer.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 (f&p) field representative that the power fail alarm of the iw990 wall mount infant warmer was not working.There was no patient involvement.

Event Description

A healthcare facility in austria reported via a fisher & paykel healthcare (f&p) field representative that the power fail alarm of the iw990 wall mount infant warmer was not working.There was no 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 and was performance tested by a trained f&p technician.Our investigation is thus based on the information provided by the regional office in germany.Results: performance testing of the iw990 infant warmer revealed that the unit's power fail alarm did not function.The fault was traced to the failure of a capacitor on the pcb.Conclusion: the subject iw990 infant warmer was released for distribution in 2016 and thus is over 5 years old.It is likely that the replaceable super capacitor on the pcb board wore out over time.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.

• 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: 11024602
• MDR Text Key: 222295795
• Report Number: 9611451-2020-01167
• Device Sequence Number: 1
• Product Code: FMT
• UDI-Device Identifier: 09420012410641
• UDI-Public: 010942001241064110210008207111160930
• 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: 11/17/2020

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: 2100082071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1