MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED COSYCOT INFANT WARMER; FMT

Model Number IW932

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw932 cosycot infant warmer was received at fisher & paykel healthcare regional office in (b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of the investigation.

Event Description

A healthcare facility in (b)(6) reported that the grill of a iw932 cosycot infant warmer was detached from the head casing.There was no patient involvement.

Event Description

A healthcare facility in the uk reported that the grill of a iw932 cosycot infant warmer was detached from the head casing.There was no patient involvement.

Manufacturer Narrative

Ps314247 method: the complaint (b)(4) cosycot infant warmer was returned to fisher & paykel healthcare (f&p) regional office in the uk, where it was inspected and performance tested by a trained f&p technician.Damaged parts were replaced and the device was returned to the customer after a functional test.Our assessment is based on the information provided by the regional office and our knowledge of the product.Results: during assessment of the device at the regional office, it was found that the head enclosure was broken.Visual inspections of the photos provided by the regional office found that the screw boss of the head enclosure was broken.Conclusion: we are unable to determine the root cause of the reported fault.The user instruction of the infant warmer states: - at least annualy check the heater head swivel is secure - ensure the head pivot nut is locked/glued in place.Check the swivel movement of head is free and that the central detente can be felt.

• Brand Name: COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8843882
• MDR Text Key: 174926543
• Report Number: 9611451-2019-00740
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW932
• Device Catalogue Number: IW932
• Device Lot Number: 120724
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1