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U.S. Department of Health and Human Services

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

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V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 29sep2020.
 
Event Description
The customer called technical support (ts) reporting that the device shutdown during patient use.The device was in clinical use at the time the reported issue was discovered.No patient harm was reported.The customer evaluated the unit and confirmed the battery needed charging.The customer states the unit did alarm low battery prior to shut down.The customer restored the power connection by pushing the power cord back together completely.The customer charged the unit's battery for 24 hours and then tested the unit.The unit passed and was returned to service.
 
Manufacturer Narrative
G4:28sep2020.B4:02apr2021.There was a patient on the unit when the issue was discovered and the ventilator was exchanged for another one.There was no reported delay in therapy, no medical intervention, no harm to the patient or user.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
MDR Report Key10603932
MDR Text Key209425717
Report Number2031642-2020-03517
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
Report Date 09/02/2020
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 Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/02/2020
Initial Date FDA Received09/29/2020
Supplement Dates Manufacturer Received09/02/2020
Supplement Dates FDA Received04/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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