MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2020.(b)(6) 2021.

Event Description

The customer reported the unit does not go into standby even though nothing is on the gas outlet port.There was no patient involvement.

Manufacturer Narrative

The device was evaluated by the philips remote service engineer (rse) and the customer.The caller is able to go into standby by pressing the button but after taking circuit off the gas outlet port, the unit does not go into standby.The caller advised that there were no significant errors in the logs.The rse advised the caller to perform pvt flow accuracy tests.Suspect is the flow sensor assembly.The rse provided the caller with the flow sensor assembly, air and o2 sensors part ids.Insufficient information is available to determine the resolution and disposition of the event.The customer was advised to provide the performance verification test results; however, no results were provided.Multiple good faith efforts (gfe) were made to obtain additional information: however, no further details were provided.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11203033
• MDR Text Key: 229870170
• Report Number: 2031642-2021-00222
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• 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
• Report Date: 07/18/2022

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: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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