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

Model Number MR290V

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that an mr290 humidification chamber was producing a rhythmic whistle.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 chamber was returned to fisher & paykel healthcare (b)(4) for evaluation and arrived in a condition which made it impossible for the investigation to be completed.Results: the chamber had been crushed and the chamber dome was cracked.The base of the dome was dented and warped.The rt265 infant breathing circuit was also damaged.A lot check revealed no other complaints of this nature for lot 140507.Conclusion: the damage to the complaint device was caused by transportation.Due to the extensive damage to the complaint device, we were unable to perform any testing and therefore were unable to determine what caused the problem reported by the customer.The user instructions which accompany the mr290 chamber state the following: - "set appropriate ventilator alarm." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." fisher & paykel healthcare has contacted the transportation company to enquire on the source of the damage which prevented the device investigation.

• 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: 4120294
• MDR Text Key: 16543885
• Report Number: 9611451-2014-00782
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2014

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: 140507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2014
• 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
• Treatment: DRÄGER INFINITY C500 VENTILATOR; FISHER & PAYKEL RT265 BREATHING CIRCUIT KIT