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

Model Number BI-PAP FOCUS SYSTEM, USA

Device Problem Defective Alarm (1014)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Submission date: 28sep2021.

Event Description

The customer reported diagnostic error "primary alarm failed".Just back from bench repair.Patient or user involvement information is unknown but has been requested.No patient or user harm was reported.The field service engineer (fse) confirmed on bootup the unit gave "primary alarm failed"."post primary audible failed" and " motor speaker: fail¿ were also found in the diagnostic in event logs.The motor controller speaker did not make any sound.The fse ordered a motor controller speaker to resolve the issue.The fse replaced the speaker assembly to resolve the issue.The unit was tested, and it was returned to service.

Manufacturer Narrative

The device was not in use on a patient.No patient or user harm was reported.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 12543680
• MDR Text Key: 273683074
• Report Number: 2031642-2021-05092
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1