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

Model Number IW980JEU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The iw980 baby control wall mount infant warmer was not returned to fisher & paykel healthcare for investigation as the customer had elected to repair the unit themselves.Our investigation is based on visual inspection of the photograph provided by the customer, our knowledge of the product, and results of previous investigations on similar complaints.Visual inspection of the photograph revealed that the harness connector housing was discoloured.Previous investigations of similar complaints revealed that the discoloured harness connectors of the infant warmers were most likely the result of arcing that occurred between two electrical contacts, leading to contact failure.The arcing was most likely caused by a poor connection.We note that the subject warmer is over 12 years old.The warmer's controller continuously monitors the power delivered to the heating element.Should the connectors completely fail the infant warmer displays an error code and enters a fail safe state where the heater element is disabled and the infant warmer alarms to allow the user to act and provide an alternate means of warming.Furthermore, the components of the harness assembly are wrapped in a fire retardant sheath, and the entire enclosure is made from fire retardant plastic.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).Replacement parts have been sent to the customer to replace the discoloured harness connectors.A trained biomed will be carrying out the service to the infant warmer.

Event Description

A hospital in (b)(6) reported that an iw980 baby control wall mount infant warmer had an error code e17.Burn marks were also observed on the upper head harness of the subject infant warmer.No patient harm 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: faranak gomarooni ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 7612570
• MDR Text Key: 111444254
• Report Number: 9611451-2018-00515
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2006
• 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