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

Model Number MR290V

Device Problems Shipping Damage or Problem (1570); Gas/Air Leak (2946); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device 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 distributor in (b)(6) reported that four mr290v vented autofeed humidification chamber have a dent in the chambers, and three of the four units caused leakage in the system which were found prior to patient use.There were no patient consequences.

Event Description

A distributor in canada reported that four mr290v vented autofeed humidification chamber have a dent in the chambers, and three of the four units caused leakage in the system which were found prior to patient use.There were no patient consequences.

Manufacturer Narrative

(b)(4).Method: one of the complaint device mr290v vented autofeed humidification chamber was received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected.Results: visual inspection revealed that the base of the chamber dome was deformed.No other damage was observed to the chamber dome.Conclusion: we are unable to determine what may have caused the reported event, however the deformity of the base most likely indicate that transport or storage related damage had occured.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.In addition, 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." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occassions, could lead to a loss of ventilation pressure." - "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: VENTED 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: 9390589
• MDR Text Key: 179285981
• Report Number: 9611451-2019-01141
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• 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: 181104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1