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U.S. Department of Health and Human Services

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

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Failure to Shut Off (2939)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 21sep2020.
 
Event Description
It was reported that the ventilator would intermittently not power off.There was no patient involvement.The customer troubleshot with technical support and was advised to replace the user interface assembly.
 
Manufacturer Narrative
G4: 04nov2020; b4: 04nov2020.Upon a follow up, the customer had reported to technical support to have received the user interface assembly and would replace it to address the reported issue.Multiple attempts were made to obtain information on the repair/service of the device that have been unsuccessful.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.
 
Manufacturer Narrative
G4: 04nov2020 b4: (b)(6) 2020 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.
 
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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
MDR Report Key10564157
MDR Text Key208745127
Report Number2031642-2020-03376
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 09/01/2020
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 No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/01/2020
Initial Date FDA Received09/21/2020
Supplement Dates Manufacturer Received09/01/2020
09/01/2020
Supplement Dates FDA Received11/04/2020
11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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