MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED BABY CONTROL WALL MOUNT INFANT WARMER; FMT

Model Number IW980JEU

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Serial number and device manufacture date: (b)(4), 04/23/2009.(b)(4), 04/23/2009.The complaint iw980jeu baby control wall mount infant warmers are not expected to be returned to fisher & paykel healthcare for investigation.We are currently in the process of obtaining further information from the hospital in order to assist us with the analysis and identification of a possible root cause of the reported event.We will provide a follow up report once we have completed our analysis.

Event Description

A hospital in (b)(6) reported that two iw980jeu baby control wall mount infant warmers had defective power fail alarm.The infant warmer units did not generate the alarm when the power cords were unplugged.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Serial number and device manufacture date: (b)(4), 04/23/2009; (b)(4), 04/23/2009.Manufacturer narrative: the complaint iw980jeu baby control wall mount infant warmers were not returned to fisher & paykel healthcare in (b)(4) for inspection.Our analysis is accordingly based on the information provided by the hospital and our knowledge of the product.The biomed technician of the hospital reported that the infant warmers did not generate an alarm when the power cords were unplugged.The "power fail" alarm circuit electrical energy source is supplied by a super capacitor in the absence of the mains power supply.The subject infant warmer units are about seven years old.It is likely that the replaceable super capacitor on the pcb board had simply worn out, causing the reported fault.The super capacitor's function is to store sufficient electrical charge to power the infant warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the "power fail" alarm of every warmer on the production line for functionality prior to distribution.The infant warmer's technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks at least once a year.Included in the infant warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.

Event Description

A hospital in (b)(6) reported that two iw980jeu baby control wall mount infant warmers had defective power fail alarm.The infant warmer units did not generate the alarm when the power cords were unplugged.No patient consequence was reported.

• Brand Name: BABY CONTROL WALL MOUNT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5395221
• MDR Text Key: 36952012
• Report Number: 9611451-2016-00025
• 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: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW980JEU
• Device Catalogue Number: IW980JEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• 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