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

Model Number BI-PAP FOCUS SYSTEM, USA

Device Problem Device Alarm System (1012)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the bi-pap indicating that the unit alarmed for 'battery low' and then shut off.It was reported there was no patient involvement at the time the issue was discovered.The unit was outside of clinical use; there was no report of harm.The investigation is ongoing.

Manufacturer Narrative

B5: philips received a complaint by the customer on the bi-pap indicating that the unit alarmed for 'battery low' and then shut off.It was reported there was no patient involvement at the time the issue was discovered.The unit was outside of clinical use; there was no report of harm.The customer evaluated the device with the assistance of the remote service engineer (rse) and the rse stated that if the unit operated between ac power and battery power as intended, but if the unit is not on a patient or a test lung that the battery will deplete quickly.The investigation concludes that no further action is required at this time.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15942236
• MDR Text Key: 305523878
• Report Number: 2031642-2022-03067
• 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,User Facility
• 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: 11/15/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2010
• 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