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

Model Number MR290V

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the complaint mr290 chamber was returned to fisher & paykel healthcare in (b)(4) and was visually inspected.Results: visual inspection revealed cracks around the base of the chamber dome, below the port and next to the hinge bracket.Residue was also observed on the inner and outer surface of the chamber dome.A lot check revealed no other complaints for lot 150617.Conclusion: the nature of the cracking and residue on the dome indicates that the damage was caused by the chamber coming into contact with a solution containing ethanol/alcohol which has resulted in environmental stress cracking of the chamber dome.Every mr290 chamber is pressure tested to 200 cmh2o following the manufacturing process to check for any leaks present in the chamber dome 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.Our user instructions that accompany the mr290v vented autofeed humidification 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 alarms.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Maximum operating pressure: 8 kpa.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that an mr290v humidification chamber dome broke after seven days of use.No patient consequence was reported.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5253630
• MDR Text Key: 32393051
• Report Number: 9611451-2015-00507
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1506170306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1