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

Model Number MR290V

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2015

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 further information from the customer 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 patient reported that an mr290v vented autofeed humidification chamber had cracked after seven hours of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare for investigation.An attempt was made to obtain additional information from the patient but no response was received.Without the complaint device or additional information from the patient, we would not be able to determine definitively the root cause of the reported fault.Every mr290 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 chamber would have met the required specification at the time of production.The crack on the chamber dome occurred after seven hours of use suggests that it was initially functioning correctly.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.".

Event Description

A patient reported that an mr290v vented autofeed humidification chamber had cracked after seven hours of use.No patient consequence was reported.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5243869
• MDR Text Key: 31980225
• Report Number: 9611451-2015-00493
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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