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

Model Number IW934JEU

Device Problems Material Discolored (1170); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The head harness connectors of the iw934jeu baby control cosycot infant warmer, are currently en route to fisher & paykel healthcare (b)(4) for further investigation.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the head harness connectors of an iw934jeu baby control cosycot infant warmer were discoloured.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint infant warmer conectors were returned to fisher & paykel healthcare (f&p) new zealand for investigation where they were visually inspected.The photographs of the burnt connectors provided by the customer were also inspected.Results: the connectors were not discoloured upon visual inspection.The photos provided by the customer were also inspected and no discolouration was observed.Conclusion: the reported fault of burnt connectors could not be confirmed.No fault was found with the returned connectors.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 13 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 healthcare facility in georgia reported that the head harness connectors of an iw934jeu baby control cosycot infant warmer were discoloured.No patient consequences were reported.

• Brand Name: BABY CONTROL COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• MDR Report Key: 8593502
• MDR Text Key: 144570711
• Report Number: 9611451-2019-00453
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934JEU
• Device Catalogue Number: IW934JEU
• Device Lot Number: 061009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1