MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HC500 SERVO CONTROLLED HEATED RESPIRATORY HUMIDIFIER

Model Number HC500

Device Problems No Audible Alarm (1019); Inappropriate Audible Prompt/Feedback (2280); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint hc500 humidifier was returned to the fisher & paykel healthcare (f&p) service centre in irvine, (b)(4) where it was inspected by a trained f&p technician on 04 april 2019.During this assessment, the speaker of the hc500 humidifier was found to be faulty.The damaged components of the humidifier are currently en route to f&p 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 a fault with a hc500 humidifier.Upon servicing of the device on 04 april 2019, it was found that the hc500 had a faulty speaker.There was no reported patient involvement.

Event Description

A healthcare facility in virginia reported a fault with a hc500 humidifier.Upon servicing of the device on (b)(6) 2019, it was found that the hc500 had a faulty speaker.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).The complaint hc500 humidifier was returned to the fisher & paykel healthcare (f&p) service centre in irvine, california where it was inspected by a trained f&p technician on (b)(6) 2019.During this assessment, the speaker of the hc500 humidifier was found to be faulty.The damaged components of the humidifier are currently en route to f&p in new zealand for evaluation.We will provide a follow-up report upon completion of our investigation.Method: the control pcb and speaker assembly of the complaint hc500 humidifier was received at fisher & paykel healthcare in new zealand for evlauation.The pcb was visually insepcted and fitted to a test jig for calibation and performance checks to performed as specified in the hc500 humidifier technical manual.A three hour soak test was conducted and the sound level of the audible alarm was also compared to a known working hc500 humidifier alarm.Results: no physical damage was observed to the complaint pcb assembly.Once fitted to the jig, the device passed calibration and performance checks as per the hc500 technical manual.No alarms were observed during the entirety of soak testing.When a heaterwire adaptor was disconnected from the test jig with the complaint pcb, the audible alarm was found to function properly.The sound level of the complaint device was found to be the same as the sound level of the known working hc500 alarm.Conclusion: we were not able to determine the cause of the reported fault of the speaker not functioning.The complaint hc500 pcb assembly was found to be functioning correctly as per specifications.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".

• Brand Name: HC500 SERVO CONTROLLED HEATED RESPIRATORY HUMIDIFIER
• Type of Device: HC500
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8580983
• MDR Text Key: 144144321
• Report Number: 9611451-2019-00433
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K953392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC500
• Device Catalogue Number: HC500
• Device Lot Number: 140408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1