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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 V60PLUS VENTILATOR
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
Philips received a complaint from the customer, reporting that the v60 ventilator had a battery with a charge that depletes easily.It was unknown how the issue was found.No patient or user harm reported.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
H10: during follow up with the key market, the responder reported that there was no patient involvement when the issue occurred.No patient or user harm reported.The responder also reported that the device displayed a "cbitbattery failed" error code.The issue was confirmed in the event log.
 
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Brand Name
V60 V60PLUS VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key18903005
MDR Text Key337649498
Report Number2518422-2024-13845
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838089280
UDI-Public(01)00884838089280
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberV60 V60PLUS VENTILATOR
Device Catalogue Number1137276
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/05/2024
Date Device Manufactured04/02/2021
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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