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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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Reported: 04jan2021.
 
Event Description
The biomed reached out to philip's remote service engineer (rse) and reported the unit will not pass touchscreen calibration.The rse advised the biomed to replace the touchscreen and provided part identification.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.
 
Manufacturer Narrative
Following the advice of the rse, the customer replaced the touchscreen to resolve the problem.The unit was functional and placed back in service.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
MDR Report Key11112802
MDR Text Key226011250
Report Number2031642-2021-00005
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 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
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
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2010
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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