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

Model Number IW980

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw980 wall mount infant warmer was returned to fisher & paykel healthcare (f&p) service centre in (b)(4) where it was visually inspected by a trained f&p service technician.Our investigation is therefore based on the photographs and information provided by the f&p service technician, and our knowledge of the product.Results: visual inspection of the subject iw980 wall mount infant warmer revealed that the head case was found to be cracked.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product and this failure mode, the observed damage on the warmer head was likely due to impact damage during transportation.The user manual for the iw980 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.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, an issue with a iw980 wall mount infant warmer.Upon servicing of the device at the fisher & paykel healthcare (f&p) service centre in germany, 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 dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 11691627
• MDR Text Key: 248817977
• Report Number: 9611451-2021-00446
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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