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

Model Number IW910JEU

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw910 mobile infant warmer was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on visual inspection of the photographs provided by the hospital, our knowledge of the product and investigations into similar complaints.Results: visual inspection of the photograph revealed that the harness connector appeared discoloured.A lot check revealed no other complaints of this nature for the lot number provided.The unit was released for distribution in 2003, indicating that the complaint infant warmer is over 12 years old.Conclusion: the upper and lower harness connectors are used to connect the head unit to the control unit of the infant warmer.Previous investigations of similar complaints revealed that the discoloured harness connector of the infant warmer is most likely the result of arcing that occurred between two electrical contacts, due to frequent swivelling of the warmer head, leading to contact failure.The arcing is most likely caused by a poor connection.The infant warmer controller continuously monitors the electrical power delivered to the heating element and when it is detected insufficient due to open circuit or a faulty harness connection, the infant warmer enters a fail-safe state (e17), ceases power to the heating element and then emits an audible and visual alarm.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by (b)(4).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 hospital in (b)(6) reported that an iw910 mobile infant warmer displayed an error code e17 and had a discoloured head harness connector.No patient consequence was reported.

• Brand Name: BABY CONTROL MOBILE 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 ; 173 technology dr. suite 100; irvine; 8007923912
• MDR Report Key: 5613922
• MDR Text Key: 43841341
• Report Number: 9611451-2016-00176
• 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
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910JEU
• Device Catalogue Number: IW910JEU
• Device Lot Number: 031201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2003
• 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