MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED BABY CONTROL MOBILE INFANT WARMER; FMT

Model Number IW910

Device Problems Electrical /Electronic Property Problem (1198); Optical Discoloration (2999)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint infant warmer is currently en route to fisher & paykel healthcare for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that an iw910 mobile infant warmer had a discoloured connector at the infant warmer head.There was no patient involvement.

Event Description

A hospital in indiana reported that an iw910 mobile infant warmer had a discoloured connector at the infant warmer head.There was no patient involvement.

Manufacturer Narrative

Ps306992 the head harness connector of the iw910 mobile infant warmer, which was reported to be discoloured, was not returned to fisher & paykel healthcare (f&p) for investigation.Our analysis is accordingly based on our previous investigations into similar complaints and our knowledge of the product.The upper and lower head harnesses are used to connect the head unit to the control unit of the infant warmer.Previous investigations on similar complaints revealed that the discoloration was most likely due to poor electrical contact caused by the degradation of the harness connectors.This degradation is likely a result of swivelling of the warmer head.It should be noted that the subject infant warmer unit was more than 11 years old.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: BABY CONTROL MOBILE INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8521219
• MDR Text Key: 142230589
• Report Number: 9611451-2019-00379
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 080306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1