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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS; V60 VENTILATOR
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RESPIRONICS; V60 VENTILATOR Back to Search Results
Model Number V60
Device Problem Inadequate User Interface (2958)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.Internal cross reference: complaint (b)(4).
 
Event Description
It was reported that the ventilator touchscreen is intermittent.There was no patient involvement.Therefore, there was no patient harmed or injured as a result of the event.The remote service engineer (rse) troubleshot the issue with the customer over the phone.The customer has performed touchscreen calibration, and the problem continues.The rse advised the customer to replace the touchscreen assembly.The rse provided the part number to the customer to address the issue.
 
Manufacturer Narrative
B4: (b)(6) 2021.The customer reported that the touchscreen was replaced, and the device is now working.No part was received for evaluation.Therefore, no root cause can be identified.If the component is returned for investigation, an assessment will be performed.
 
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Brand Name
RESPIRONICS
Type of Device
V60 VENTILATOR
MDR Report Key11401829
MDR Text Key234435040
Report Number2031642-2021-03000
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public00884838020054
Combination Product (y/n)N
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 Date06/21/2021
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received03/02/2021
Supplement Dates Manufacturer Received06/21/2021
Supplement Dates FDA Received06/23/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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