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

Model Number IW980JEU

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4), method: the complaint iw980 baby control wall mount infant warmer was returned to the fph service center in (b)(6) where it was inspected by a trained fph service engineer.The defective heating element and the upper and lower head harness connectors were returned to fph (b)(4) for further investigation.Our analysis is accordingly based on the information and photographs provided by fph service engineer, results of the investigation conducted at fph (b)(4), and previous investigations on similar complaints.Results: initial inspection conducted at the fph service center revealed that the head case was discoloured and damaged.The unit also registered error code e17 during inspection, which was isolated to the heating element and head harness.Further inspection conducted at fph (b)(4) showed that the upper and lower harness connector housing had slight discolouration.The returned heating element passed the electrical resistance test; however, its spade terminal and tab were also discoloured.Conclusion: the discolouration observed on the head case is related to a known problem of incompatible cleaning solutions reacting with the polycarbonate plastic and acrylic components of the infant warmer.When the warmer head begins to warm up during use, a chemical reaction with the incompatible cleaning solution results in gradual cracking and crazing of the warmer head.The product technical manual of the infant warmer features a diagram of the infant warmer which highlights the plastic surfaces of the unit containing components made from polycarbonate or acrylic, and states the following: "caution do not clean the highlighted plastic surfaces with proprietary cleaning products containing hydroxides, hypochlorites, peroxides, gluteraldehyde or cleaning products with a greater than 30% alcohol base." "caution the chemicals used in these proprietary cleaning products may lead to discolouration, crazing and eventual cracking of the highlighted plastic surfaces." we have since revised our cleaning instructions to recommend specific proprietary cleaning products.The upper and lower harnesses 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 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.It was also noted in our previous investigations that swivelling of the warmer head also contributed to this type of failure.The heating element terminal impairment can be attributed to the progression of heat at the connectors, leading to loose terminal connection.It eventually causes enough degradation and breaks the electrical power to the heating element due to open circuit.This failure mode is expected as part of the component's expected wear and tear.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).The entire harness is enclosed in a ul v-0 rated fire retardant enclosure.Should the connectors completely fail during the operation, an audible and visual alarm 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.The subject infant warmer is almost 10 years old and a reasonable level of wear and tear is expected.The iw980 baby control wall mount infant warmer was repaired and returned to the medical center after passing electrical safety test and performance checks specified in the infant warmer product technical manual.

Event Description

A medical center in (b)(6) reported that the iw980jeu baby control wall mount infant warmer had a persistent "see manual" light, which sometimes took about 30 minutes to show up.This was observed during use on a patient; however, no consequence was reported.The medical center also requested to service the unit.

• 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: jon stevens ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6363374
• MDR Text Key: 68467367
• Report Number: 9611451-2017-00113
• 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
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2007
• 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