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

Model Number BIPAP FOCUS SYSTEM, INT'L, RENTAL

Device Problem Increase in Pressure (1491)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Event Description

The customer reported a high-pressure alarm.The device was in clinical use at the time the reported issue was discovered.There was no patient or user harm.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The customer reported a high-pressure alarm however there was no audible alert.There was no patient involvement.

Manufacturer Narrative

H11:b5:the customer reported a high pressure alarm with audible alert.H10: the authorized service provider (asp) checked the cause of fan failure and adjusted the machine.The asp determined the ventilator is ready for use after successful adjustment.

Manufacturer Narrative

The device was in clinical use.No patient harm was reported.

Manufacturer Narrative

The authorized service provider (asp) started the machine to check the running condition and check the oxygen input pressure.The asp determined the oxygen pipeline was the problem.The asp determined the ventilator is ready for use after replacing the oxygen pipeline and controlling the air flow.

• 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: 13830991
• MDR Text Key: 287699336
• Report Number: 2031642-2022-00712
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• 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?: No
• Date Manufacturer Received: 05/05/2022
• Date Device Manufactured: 06/20/2008
• 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