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

Model Number	HC550JHU
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint hc550 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) (b)(4).We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that an hc550 respiratory humidifier did not generate audible alarm.There was no reported patient consequences.
Additional Manufacturer Narrative
(b)(4).Method: the complaint hc550 respiratory humidifier was returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected and electrically evaluated.Results: visual inspection revealed no signs of impact damage.Performance testing revealed that the audible alarm was heard.Conclusion: we are unable to determine what caused the reported event as no fault was found with the device.The hc550 is equipped with visual alarm indicators in addition to the audible alarm.
Event or Problem Description
A healthcare facility in texas reported that an hc550 respiratory humidifier did not generate audible alarm.There was no reported patient consequences.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• MDR Report Key: 9379611
• Report Number: 9611451-2019-01134
• Device Sequence Number: 19507214
• Product Code: BTT
• UDI-Device Identifier: 09420012416810
• UDI-Public: (01)09420012416810(10)2100559669(11)180815
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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
• Operator of Device: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1