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

Model Number MR290V

Device Problems Crack (1135); Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 autofeed humidification chambers were received today at fisher & paykel healthcare in (b)(4).We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that two mr290v humidification chambers were leaking.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the two complaint mr290v chambers were returned to fisher & paykel healthcare in new (b)(4) and were visually inspected.Results: visual inspection revealed that for both complaint devices, the chamber dome was cracked.Visual inspection of device 1 revealed that the dome was cracked along the base, starting below the port and ending below the baffle.A second crack was found above the bracket.Residue was observed in several places on the outer surface of the chamber dome.For device 2, visual inspection revealed that the chamber dome was also cracked along the base, starting below the port and ending below the baffle.Residue and flow marks were also observed in several places on the outer surface of the chamber dome.A lot check revealed no other complaints of this nature for lot 150727.Conclusion: the residue found on the chamber domes indicates that the chambers came in contact with a solution containing alcohol which resulted in environmental stress cracking of the chamber domes.Every mr290 chamber is pressure tested 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.

Event Description

A hospital in (b)(6) reported that two mr290v humidification chambers were leaking.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: 5309148
• MDR Text Key: 33834466
• Report Number: 9611451-2015-00535
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 11/20/2015

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: 150727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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