MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number BIPAP FOCUS SYSTEM, INT'L, RENTAL

Device Problem Unintended Power Up (1162)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

The customer reported that when the ventilator is placed in standby that the unit will power itself on and alarms.There was no patient involvement.No harm reported.The remote service engineer spoke with the customer who said the switch feels ok, it has a new battery, and the error log contains error codes 105 and 436.(ec 105) is an unexpected shutdown and (ec 436) is why the unit shutdown, either a battery or user interface issue due to 18v boost failure.The rse suggested the customer would need to replace the user interface board.The customer was provided information that the device was end of life and there is no availability of material to repair the device.

Manufacturer Narrative

No new information has been provided regarding the complete repair of the device at this time.Since the device has reached its end of life, no repair part will be sent to the customer.If repair information becomes available at a later date, a supplemental report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12857923
• MDR Text Key: 285679894
• Report Number: 2031642-2021-05585
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: BIPAP FOCUS SYSTEM, INT'L, RENTAL
• Device Catalogue Number: R1033869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/24/2021
• Date Device Manufactured: 12/15/2008
• 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