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

Model Number IW980

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the infant warmer was not returned to fisher & paykel healthcare for evaluation as the hospital had elected to repair the unit themselves.Our investigation is therefore based on the photograph and information provided by the hospital.Results: inspection of the provided photograph revealed that the head harness connector was incorrectly assembled and there was discolouration of the head harness housing connector on the slot where the neutral and phase wire terminal is located.Conclusion: the incorrect assembly of the harness connectors had caused an open circuit.The upper and lower harnesses are used to connect the head unit to the control unit of the infant warmer.Loss of electrical contact will lead to degradation of the harness connector and result in an error 17 condition.From the information provided by the hospital we have noted that the infant warmer harness was replaced in (b)(6) 2011 and the technician incorrectly assembled the harness connector at that time.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).Should the connectors completely fail during the operation, an audible and visual alarm (e17, as reported by the customer) 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.An infant warmer harness spares kit was sent to the customer in order for the biomed to repair the subject warmer unit.

Event Description

A hospital in (b)(6) reported that an iw980 wall mount infant warmer was displaying an e17 error code and that the heater element harness connectors were discoloured.This was found before patient use.

• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7176572
• MDR Text Key: 97732066
• Report Number: 9611451-2018-00010
• 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
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• 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
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2008
• 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