MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BABY CONTROL COSYCOT INFANT WARMER; FMT

Model Number IW934

Device Problems Crack (1135); Overfill (2404)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of investigation.

Event Description

A hospital in (b)(6) reported that a iw934 cosycot infant warmer had a cracked base.There was no patient involvement.

Manufacturer Narrative

(b)(4).Incorrect report was submitted for follow up report #1.Method: the complaint iw934 baby control cosycot infant warmer was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the photograph provided by the hospital, our knowledge of the product and previous investigations into similar complaints.Results: the photograph revealed that the plastic base was cracked through at the base of one of the legs.Conclusion: cracking of the base plastic legs of the cosycot infant warmer is known to occur due to accessories overloading the maximum weight capacity of 115kg (including accessories).The maximum weight limit is specified in the operating manual and in the product technical manual of the cosycot infant warmer.To increase awareness and to prevent and/or reduce the incidence of cracked plastic bases, f&p states that the maximum weight on the infant warmer inclusive of all accessories and the patient should not exceed 115kg.This warning is provided in the form of labels on the column of the infant warmer.In addition, a checklist of common fisher & paykel healthcare accessories and their respective weights is provided to the user.It should be noted that the subject complaint was at least twelve years so, it is therefore reasonable to expect wear and tear.

Event Description

A hospital in australia reported that a iw934 cosycot infant warmer had a cracked base.There was no patient involvement.

Event Description

A distributor in japan reported on behalf of a healthcare facility to a fisher & paykel healthcare (f&p) field representative that an mr290v vented autofeed humidification chamber was overfilled immediately after starting to use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Visual inspection and water level testing of the returned mr290 chamber was performed.Results: visual inspection revealed no damage to the chamber.The floats were found to be moving freely.During the functional test, the water level of both primary and secondary floats was checked.Both floats operated correctly, and the water level attained was within specification.Conclusion: we were unable to determine the cause of the reported issue, as the complaint mr290 chamber was found to be operating correctly.Overfilling of water is usually caused by both the primary and secondary float mechanisms in the mr290 chamber being disabled.In circumstances where the primary float is disabled, the water may overfill above the black water level line of the chamber but the secondary float will serve as a backup to prevent the water from overflowing outside the chamber port and entering into the breathing circuit.All mr290 chambers have float function and valve testing performed twice during production.A failure of any test would result in rejection of the chamber before distribution.The user instructions that accompany the mr290 humidification chamber specify in the warning section "do not use the chamber if the water rises above the maximum water level line" along with a diagram directing the user to check the water level on the chamber.A written description of the meaning of the symbols used is also included in the user instructions.It also states the following: "set appropriate ventilator alarm." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• Brand Name: BABY CONTROL COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9169977
• MDR Text Key: 177176151
• Report Number: 9611451-2019-00971
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934
• Device Catalogue Number: IW934
• Device Lot Number: 070529
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/23/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1