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

Model Number BIPAP FOCUS SYSTEM, INT'L, RENTAL

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2022

Event Type  Death  

Event Description

The institutional biomedical engineer (bme) reported that the patient passed away.A respiratory technician found the mask halfway off the face of the user.The device did alarm and was working well before the incident.A patient of unknown age, gender and medical history was placed on the bipap focus for an unknown indication.On (b)(6) 2022, while the device was in clinical use, the patient passed away.A respiratory technician found the mask to be halfway off the patient¿s face.The customer indicated that the device did alarm and was working well before the incident.No other clinical details were provided.The customer requested for an on-site service.As end-of-life classification of manufacturing, distribution, and use of bipap focus has been designated as of (b)(6) 2019, a philips remote service engineer (rse) provided a product discontinuance letter to the customer and was advised to find a third party to service the ventilator.The rse also reached out to sales to find out if an area manager (am) has knowledge of the bipap focus to provide assistance with any questions.The customer is seeking 3rd party evaluation of the device.Further information have been requested regarding this event.

Manufacturer Narrative

Based on information received from the respiratory therapist director, it was indicated that there was no device malfunction and identified it as a patient issue.The respiratory therapist director indicated that the device was alarming as designed in the event of the absence of spontaneous breath.Based on the information received the device was operating per the design specifications.

• 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: 15280188
• MDR Text Key: 298454252
• Report Number: 2031642-2022-02216
• 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?: Yes
• 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?: Yes
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/15/2022
• Date Device Manufactured: 07/26/2006
• 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
• Patient Outcome(s): Death