MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Increase in Pressure (1491)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit high o2 supply pressure alarm.Based upon the information provided, the device was in clinical or providing therapy at the time of the event reported.No harm or injury has been indicated or alleged.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device and diagnostic report, the biomed had alarming.He claims they used tanks while their medgas system was down.He stated the 02-inlet pressure was reading 108 psi.After disconnecting 02 from the wall outlet, the 02-inlet pressure was still around 108 psi.After he started to loosen the 02 hose from the manifold to the back of the unit, he had the 02 leak out.After disconnecting the 02 hose from the back of the unit, the 02-inlet pressure dropped to 0.There was 02 pressure built up in that area, and the unit was reading over 100 psi.He verified there was a 1208 and 120a error codes in the significate log.He turned the unit on in patient mode and there were no issues.It is unknown if any parts or repairs have been conducted about the alleged complaint.

Manufacturer Narrative

The device was being set up for use at the time of the reported event.No harm or injury has been indicated or alleged.As previously stated, the biomed found after disconnecting the o2 hose from the back of the unit, the o2 inlet pressure dropped to 0, he turned the unit on inpatient mode, and there were no issues.The biomed disconnected the o2 source from the ventilator, then reconnected the o2 source.The device was placed back into service.No parts were replaced.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• 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: 13721399
• MDR Text Key: 286939154
• Report Number: 2031642-2022-00635
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2022
• Date Device Manufactured: 05/20/2020
• 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