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 10/14/2021

Event Type  malfunction  

Event Description

It was reported that the device shut off during testing, and there¿s "pressure regulation high" error in the v60 significant event log.The device was in use.The unit was swapped out for another one, there was no patient or user harm reported.The customer confirmed diagnostic " pressure regulation high" in the v60 significant event log.The customer stated that the proximal pressure was 25 cmh2o greater than the pressure limit listed below and greater than the hip setting for 1 second ± 20 msec pressure limit.The remote service engineer (rse) advised customer to complete pneumatics performance verification testing.

Manufacturer Narrative

The biomed reported the v60 had passed all performance verification testing.The customer was advised to run the unit for 24 hours and attempt to reproduce the error.The customer was also advised that the recommended repair is to replace the data acquisition board.Further information has been requested.

Manufacturer Narrative

Multiple attempts were made to follow-up with the customer to obtain additional information; however, there was no response.If additional information is received at a later date, this complaint will be re-opened and re-evaluated accordingly.

• 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: 12787135
• MDR Text Key: 280587181
• Report Number: 2031642-2021-05498
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 08/16/2022
• Date Device Manufactured: 12/13/2019
• 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