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

Model Number IW990

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw990 wall mount infant warmer was returned to fisher & paykel healthcare service centre in france for service, where it was visually inspected by a trained f&p technician.Our investigation is thus based on the information provided by our service centre in france.Results: during device servicing, the head case of the infant warmer was found to be cracked.Conclusion: we are unable to determine the cause of the cracked infant warmer head.The warmer head of the iw990 wall mount infant warmer can be swivelled 130 degrees from the center and is susceptible to impact damage, particularly if the head is swivelled.It is also worth noting that the subject iw990 wall mount infant warmer is over 16 years old.The user manual for the iw990 wall mount infant warmer states "ensure all warmer parts and accessories are checked before returning the device to service".The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks at least once a year.The subject infant warmer was repaired and was returned to the customer after passing all the required safety and performance tests.

Event Description

A healthcare facility in (b)(6) requested, via a fisher & paykel healthcare (f&p) field representative, a routine service for an iw990 wall mount infant warmer.Upon device servicing at the regional office, it was discovered that the head case was cracked.There was no patient involvement.

• Brand Name: WALL MOUNT WARMER MANUAL
• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 11333998
• MDR Text Key: 241949431
• Report Number: 9611451-2021-00166
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990
• Device Catalogue Number: IW990
• Device Lot Number: 040820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2004
• 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