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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 Problems Defective Alarm (1014); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 31jul2020.
 
Event Description
The customer reported a ventilator with a primary alarm failure.The manufacturer's field service engineer confirmed the reported problem, and further confirmed this issue by observation of a speaker failure alarm during a power-on self-test in the event's history log.It was unknown if this event occurred in patient use.There was no allegation of harm associated with this event.The manufacturer's field service engineer replaced speaker assembly (#2) to resolve this reported event.
 
Manufacturer Narrative
The reported issue was confirmed an electrical open circuit in the speaker generated the reported failure of the primary alarm.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key10353691
MDR Text Key202480542
Report Number2031642-2020-02602
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public(01)00884838020054
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 07/15/2021
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
Device Catalogue Number1053617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/09/2020
Initial Date FDA Received07/31/2020
Supplement Dates Manufacturer Received05/11/2021
Supplement Dates FDA Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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