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

Model Number IW934

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining additional information from the customer, to determine if the complaint iw934 cosycot infant warmer had a malfunction which caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the power fail audio alarm of an iw934 cosycot infant warmer had failed.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint iw934 cosycot infant warmer was not returned to fisher & paykel healthcare (fph) in (b)(6) for investigation.Our investigation is therefore based on the information provided by the hospital.Result: we were informed by the hospital that the transformer resistance on the primary winding was open circuit and this caused the power fail alarm to be triggered.Conclusion: no failure was detected as the cosycot operated within specification.The cosycot power fail alarm will trigger when the power supply to the cosycot has failed.

Event Description

A hospital in (b)(6) reported that the power fail alarm of an iw934 cosycot infant warmer had failed.It was later discovered that the power fail alarm had triggered, not failed.There was no patient involvement.

• Brand Name: COSYCOT 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: 7150179
• MDR Text Key: 95936304
• Report Number: 9611451-2017-01247
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971695
• 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,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934
• Device Catalogue Number: IW934
• Device Lot Number: 090504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2009
• 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