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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 Tidal Volume Fluctuations (1634)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2024
Event Type  malfunction  
Event Description
Philips received a complaint from the customer, reporting that the v60 ventilator was not producing volumes.It was unknown how the issue was found.No patient or user harm reported.
 
Manufacturer Narrative
E1: reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).G1: contact office phone: (b)(4).
 
Manufacturer Narrative
Per the service record, a diagnosis was performed by an engineer, and it was reported that the device required a replacement blower.The repair is pending.
 
Manufacturer Narrative
H10: the service record was updated to note that the device was not in clinical use when the issue occurred.No patient or user harm reported.A service engineer (se) repaired the device, and replaced the blower assembly.The system meets the specification for the performed service and is returned to use.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.
 
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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
melissa rosko
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key19096757
MDR Text Key340342159
Report Number2518422-2024-19123
Device Sequence Number1
Product Code MNT
UDI-Device Identifier989805658561
UDI-Public(01)989805658561
Combination Product (y/n)N
Reporter Country CodePO
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,Followup,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 Model NumberV60 V60PLUS VENTILATOR
Device Catalogue Number1137276
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/12/2024
Supplement Dates Manufacturer Received04/12/2024
05/13/2024
Supplement Dates FDA Received04/18/2024
05/20/2024
Date Device Manufactured05/13/2020
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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