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

Model Number MR290V

Device Problem Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: three complaint mr290v vented autofeed humidification chambers (device 1 and 2: lot 140401, manufactured on 1 april 2014; device 3: lot 150413, manufactured on 13 april 2015) were returned to fisher & paykel healthcare in (b)(4) and were visually inspected.Results: visual inspection revealed that for all three complaint devices, the chamber dome was cracked.Visual inspection of device 1 revealed a crack below the port and the printing on the dome was observed to be smeared.For device 2, visual inspection revealed a crack below the port and residue was observed around the crack.Visual inspection of device 3 revealed a crack around the base of the chamber dome.The crack started blow the port and to the hinge bracket.Residue was observed around the crack.A lot check revealed no other complaints of this nature for lot 140401 and one other complaint of this nature for lot 150413.Conclusion: the smeared print and residue on the devices indicate that the chambers were 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 via an fisher & paykel healthcare field representative that three mr290 humidification chambers were found "defective" during use.Further information revealed that the chambers were cracked.No patient consequence was reported.

• Brand Name: HIGH FREQUENCY 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: 5265630
• MDR Text Key: 32660374
• Report Number: 9611451-2015-00516
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/05/2015

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: 140401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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