MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber is currently en route to fisher & paykel healthcare (f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that an mr290v vented autofeed humidification chamber dome was deformed and leak occured during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare in new zealand for investigation.The chamber was visually inspected for the reported damage.Results: the bottom part of the chamber dome was found deformed and the dome flange was loosened up.There was no sign of physical scratch or crack around the deformed area.It was also observed that the gasket was discolored.The leak was observed when the deformed chamber was connected to the water source.Conclusion: we are unable to determine what may have caused the reported event.The customer stated that the chamber was in use for a month before the reported event.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.Also, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chambers would have met the required specification at the time of production.The user instructions that accompany the mr290v vented autofeed humificiation chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "set appropriate ventilator alarm." "perform pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

Event Description

A healthcare facility in japan reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that an mr290v vented autofeed humidification chamber dome was deformed and leak occured during use.There was no reported patient consequence.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9518664
• MDR Text Key: 181952890
• Report Number: 9611451-2019-01247
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 181011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1