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

Model Number IW980

Device Problems Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the infant warmer was not returned to fisher & paykel healthcare for evaluation as the customer had elected to repair the unit themselves.A photograph showing the heater head damaged parts was received.Results: inspection of the provided photograph revealed discolouration of the head harness housing connector on the slot where the neutral and phase wire terminal is located.Conclusion: degradation of the heater element leading to open circuit is usually the result of normal aging failure.We note that the subject warmer is over eight years old.The upper and lower harnesses are used to connect the head unit to the control unit of the infant warmer.Possible loss of electrical contact due to early degradation of the harness connector before its 10 year service life will result in an error 17 condition.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by (b)(4).Should the connectors completely fail during the operation, an audible and visual alarm (e17, as reported by the customer) will be registered on the front control panel of the infant warmer, thereby allowing the hospital staff time to act and provide other means of warming.An infant warmer harness spares kit was sent to the customer in order for the biomed to repair the subject warmer unit.

Event Description

A hospital in (b)(6) reported that an iw980 wall mount infant warmer was displaying an e17 error code and that the connections were burnt.No patient consequence was reported.

• Brand Name: WALL MOUNT 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; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5411987
• MDR Text Key: 37851296
• Report Number: 9611451-2016-00039
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• 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
• Device Lot Number: 071207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2007
• 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