MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number HC500

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the leds on an hc500 humidifier were not functioning on start up.They have further requested a repair of the device.This was found prior to patient use.

Manufacturer Narrative

(b)(4).Method: the complaint device was returned to our service centre in france where it was visually inspected and the leads were checked by a trained fisher & paykel healthcare (fph) service engineer.The complaint device was then sent to fph in (b)(4) for further investigation.Results: visual inspection revealed no damage to the device.The leds did not light up and were not operational upon switching the device on or when an alarm was triggered.However the audible alarm was still operational.Evidence of water ingress was noted on the control pcb.A lot check revealed no other complaints for lot 111221.Conclusion: based on the inspection carried out it is likely that the damage observed was caused by excess water ingress on the control pcb.Our hc500 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the hc500 humidifier.In addition the operating manual advises that "in the event that an alarm code is displayed, the hc500 will require service.Please take a note of the code and advise the technician".Moreover, it warns the user to never operate the hc500 if any part of the hc500 is dropped or damaged or dropped into water.To date this is the only complaint we have received of this nature for the hc500 humidifier.

Event Description

A healthcare facility in (b)(6) reported that the leds on an hc500 humidifier were not functioning on start up.They have further requested a repair of the device.This was found prior to patient use.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• 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 ; 9194534000
• MDR Report Key: 5506855
• MDR Text Key: 40833236
• Report Number: 9611451-2016-00097
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HC500
• Device Catalogue Number: HC500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1