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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2023
Event Type  malfunction  
Event Description
Philips received a complaint on the v60 ventilator, indicating that the display was discolored.Discovered outside of clinical use and no reports of patient/user harm or injury.Customer reports the screen was replaced and the device was working without discoloration.The device was tested and returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
 
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Brand Name
RESPIRONICS
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 Key16875592
MDR Text Key314646458
Report Number2518422-2023-10470
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public00884838020054
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Date Device Manufactured06/02/2016
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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