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

Model Number IW910

Device Problems Material Discolored (1170); Electrical /Electronic Property Problem (1198)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw910 mobile 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 (b)(6) reported that the iw910 mobile infant warmer heating element was discoloured on a harness.There was no patient involvement.

Event Description

A healthcare facility in oregon reported that the iw910 mobile infant warmer heating element was discoloured on a harness.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint harness and heating element of an iw980 wall mount infant warmer were returned to fisher & paykel healthcare in new zealand where it was visually inspected and continuity was measured with a multimeter.Results: visual inspection of the returned device revealed that the harness connectors were discoloured.However, there was still continuity in the conductors when measured with a multimeter.Conclusion: the harness is used to connect the head unit to the control unit of the infant warmer.Previous investigations of similar complaints revealed that the discoloured harness connectors of the infant warmers were most likely the result of arcing that occurred between two electrical contacts, leading to contact failure.The arcing was most likely caused by a poor connection.It should be noted that the subject infant warmer unit was more than 14 years old at the time of the reported malfunction and a reasonable level of wear and tear is expected.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).The entire harness is enclosed in a ul v-0 rated fire retardant enclosure.Should the connectors completely fail, the infant warmer displays an error code and enters a fail safe state where the heater element is disabled and the infant warmer alarms to allow the user to act and provide an alternate means of warming.The infant warmer technical/service manual also contains a checklist which specifies that users perform safety, performance, and functional checks at least once a year.

• Brand Name: MOBILE 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: 11479019
• MDR Text Key: 243901048
• Report Number: 9611451-2021-00284
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K970432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910
• Device Catalogue Number: IW910
• Device Lot Number: 070501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1