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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device was not measuring volumes accurately.The device was not in clinical use at the time of the event.There was no report of patient or user harm/impact.The customer requested that a philips field service engineer (fse) be dispatched to the customer site to provide additional assistance.
 
Manufacturer Narrative
The field service engineer (fse) replaced the flow sensor assembly to resolve the reported issue.The unit passed performance verification testing, and it was returned to service.The device was not being used for medical treatment, no patient or user harm was reported.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
MDR Report Key11803605
MDR Text Key249995540
Report Number2031642-2021-03674
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public00884838020054
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
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
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date04/12/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/10/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received10/27/2021
Date Device Manufactured06/23/2014
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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