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

Model Number BI-PAP FOCUS SYSTEM, USA

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit's lcd is no longer back layering.Based upon the information provided, it is unknown if the unit was in use on a patient at the time of the reported event, however, no patient harm or injury was reported.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device, the biomed stated lcd is no longer back layering and was requesting part numbers.The rse informed customer unit is no longer supported and provided customer with bipap focus discontinuation letter.It is unknown if any parts or repair has been conducted in relation to the alleged complaint.Attempts to obtain further information are currently pending.

Manufacturer Narrative

Upon further investigation, the following information was received indicating that the unit was not on a patient or in use.Therefore this complaint no longer meets reportability requirements.

• 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: 13011442
• MDR Text Key: 282286280
• Report Number: 2031642-2021-05787
• 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: BI-PAP FOCUS SYSTEM, USA
• Device Catalogue Number: 1028772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/04/2022
• Date Device Manufactured: 08/24/2007
• 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