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

Model Number MR850

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the pcb of the complaint mr850 was received at our fisher & paykel healthcare regional service centre in (b)(4), where it was visually inspected and electrically evaluated.Results: visual inspection revealed signs of impact damage.The device's enclosure was broken and appeared to have suffered damage from impact or from being dropped.Performance testing revealed that the audible alarm could not be heard.Previous investigations into alarm buzzer failure have found that the coil resistance was open circuit.Conclusion: we are unable to determine what may have caused the open circuit, but the combination of old age (the device is 14 years old), wear and tear, and the noted physical damage were all likely contributors.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 heater base.In addition the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 is equipped with visual alarm indicators in addition to the audible alarm.The subject mr850 was repaired and returned to the customer after passing the performance tests specified in the product technical manual.

Event Description

A hospital in (b)(6) reported that the audible alarm of an mr850 respiratory humidifier had failed.There was no patient involvement.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 7146962
• MDR Text Key: 96023952
• Report Number: 9611451-2017-01243
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 030827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2003
• 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