MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problems Battery Problem (2885); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13jan2021.

Event Description

The customer reported battery issues and the ventilator was changed out.The ventilator was in use on a patient.The patient was supported with 100% oxygen mask during the ventilator swap.The patent tolerated the oxygen mask okay until the ventilator swap was completed.The customer reports battery issues in use.The ventilator went on transport and after transport it was connected to ac power.The ventilator stated low battery and the customer said the ventilator stated there was a warm battery then the unit shut down.The remote service engineer advised the customer to check the significant event log which showed key stuck.The rse advised the customer that the device is end of life and philips no longer offers any service for the device.The rse advised the customer to replace the battery and run the unit on a test lung with combination of ac and dc operation to see if the issue could be duplicated.The rse provided the customer with the service manual.The customer performed the testing as advised by the rse and installed a new battery.The issue is resolved.

Manufacturer Narrative

Based on reevaluation, this complaint has been downgraded from a serious injury to product problem as the administration of 100% oxygen is a standard clinical approach when a patient is being swapped to another mechanical ventilator (settings, configuration, make/model unspecified).This was well tolerated by the patient, with no reported harm or injury incurred.

Manufacturer Narrative

G4:18feb2021.B4:19feb2021.H10: type of report changed from non-adverse event to serious injury due to the provision of medical intervention to preclude harm to the patient.The patient was supported with the application of oxygen mask.Patient information: female, 77 years old, weight-unknown, condition ¿poor.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11167724
• MDR Text Key: 227922527
• Report Number: 2031642-2021-00150
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 12/17/2020; 02/21/2022
• Supplement Dates FDA Received: 02/19/2021; 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2007
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Age: 77 YR
• Patient Sex: Female