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

Model Number IW980

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The infant warmer was not returned to fisher & paykel healthcare for evaluation as the customer had elected to repair the unit themselves.We requested and received photographs in which the reported discolouration of the connectors are clearly visible.Results: visual inspection revealed that the connectors on the head harnesses were discolored.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.The subject infant warmer is 2 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.

Event Description

A hospital in (b)(6) reported that an iw980 wall mount infant warmer had an error code.It was also reported that the heater element connectors and head harness connectors were discoloured.No patient consequence was reported.

• Brand Name: WALL MOUNT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7150111
• MDR Text Key: 95927939
• Report Number: 9611451-2017-01248
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/07/2017

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: IW980
• Device Catalogue Number: IW980
• Device Lot Number: 080815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1