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

Model Number IW980

Device Problems No Audible Alarm (1019); Device Issue (2379)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was not made available by the healthcare facility for evaluation.We are currently in the process of conducting an investigation based on the reported information.We will submit a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the power failure alarm of an iw980 wall mounted infant warmer did not emit when the power cord was disconnected.There was no patient involvement.

Manufacturer Narrative

(b)(4).The complaint (b)(4) wall mount infant warmer unit was not made available to fisher & paykel healthcare in (b)(4) for investigation.Our analysis is accordingly based on the information provided by the hospital and our knowledge of the product.Without the return of the complaint device we are unable to determine what may have caused the reported event.We note that the complaint device is approximately 8 years old.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every infant warmer on the production line for functionality prior to distribution.The infant warmer's technical/service manual contains a checklist which specifies that user perform safety, performance and functional checks including the power fail alarm at least once a year.The hospital has since reported that the subject infant warmer was decommissioned and is no longer in use.

Event Description

A hospital in (b)(6) reported that the power failure alarm of an (b)(4) wall mounted infant warmer did not emit when the power cord was disconnected.There was no patient involvement.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6197487
• MDR Text Key: 63066403
• Report Number: 9611451-2016-00905
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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: 090423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2009
• 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