MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD IW930 COSYCOT INFANT WARMER; FMT

Model Number IW930

Device Problems Material Discolored (1170); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw930 cosycot infant warmer is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A medical center in (b)(6) reported that the head harness connector of an iw930 cosycot infant warmer was discolored and the heating element did not have any resistance.It was also reported that the complaint infant warmer produced an error e17.No patient involvement was reported.

Manufacturer Narrative

Ps297653 method: the complaint infant warmer head harness was returned to fisher & paykel healthcare (f&p) new zealand for investigation where it was visually inspected.Results: visual inspection of the infant warmer head harness confirmed the reported discoloration.Conclusion: the upper and lower harnesses are used to connect the head unit to the control unit of the infant warmer.Previous investigations of 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 in conjunction with the normal aging of the heating element parts.The subject infant warmer is over 12 years old 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 during the operation, an audible and visual alarm will be registered on the front control panel of the infant warmer, thereby allowing the hospital staff time to act and provide other 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.

Event Description

A medical center in south carolina reported that the head harness connector of an iw930 cosycot infant warmer was discolored and the heating element did not have any resistance.It was also reported that the complaint infant warmer produced an error e17.No patient involvement was reported.

• Brand Name: IW930 COSYCOT 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: 8255237
• MDR Text Key: 133330228
• Report Number: 9611451-2019-00033
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW930
• Device Catalogue Number: IW930
• Device Lot Number: 060614
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1