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

Model Number IW932JEU

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital, including photographs, to determine if the complaint head harness connectors of the subject iw932jeu baby control cosycot infant warmer had a malfunction, which could have caused or contributed to the reported event.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported that the head harness connectors of an iw932jeu baby control cosycot infant warmer were discoloured.No patient consequence was reported.

Event Description

A hospital in (b)(6) reported that the head harness connectors of an iw932jeu baby control cosycot infant warmer were discoloured.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The head harness connectors of an iw932jeu baby control cosycot infant warmer, which were reported to be discoloured, were not returned to fisher & paykel healthcare (fph) for investigation.An attempt was made to obtain photos of the discoloured head harness connectors but no response was received from the hospital.Our analysis is accordingly based on our previous investigations on 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 nine years old at the time of the reported malfunction.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 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: 7119477
• MDR Text Key: 95081323
• Report Number: 9611451-2017-01203
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW932JEU
• Device Catalogue Number: IW932JEU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1