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 mr290v vented autofeed humidification chamber is not available for investigation.We are currently in the process of obtaining the device and further information from the hospital in order to investigate the reported incident.We will provide a follow up report after we receive further information and have completed our analysis.

Event Description

A hospital in (b)(6) reported via an fisher & paykel healthcare field representative that a mr290 humidification chamber was found damaged during use.No further information was received regarding the nature of the reported damage.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber was 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 via an fisher & paykel healthcare field representative that a mr290 humidification chamber was found damaged during use.It has since been reported that the nature of the damage is a crack.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: one mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected.The hospital had also provided additional information, reporting that it was possible for the chamber to have got into contact with a hand disinfection solution.Therefore our investigation is based on evaluation of the returned device, information reported by the hospital, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the returned chamber revealed a crack around the base of the chamber dome, between one port and the hinge bracket.Residue and smeared print marks were also observed on the chamber dome.A lot check revealed no other complaints of this nature of lot 150415.Conclusion: the nature of the cracking, residue and smeared printing suggest 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 an fisher & paykel healthcare field representative that a mr290 humidification chamber was found damaged during use.It has since been reported that the nature of the damage is a crack.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: 5283278
• MDR Text Key: 33107305
• Report Number: 9611451-2015-00525
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 150415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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