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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 V60PLUS VENTILATOR
Device Problem Tidal Volume Fluctuations (1634)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2024
Event Type  malfunction  
Event Description
Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device was not showing volumes.The device was in use on a patient at the time the reported issue was discovered; however, there was no reported harm to the patient or user.The biomedical engineer (bme) called technical support to report that the device was not showing volumes.The bme was not in front of the device and could not perform troubleshooting, so the bme requested onsite service since the device was under contract.The remote service engineer (rse) created an onsite work order (wo) per the bme's request, and an authorized service provider (asp) was dispatched onsite to evaluate and repair the device.Upon arrival, the asp confirmed the reported issue and replaced the gas delivery system (gds) per the service manual.After replacing the gds, the asp verified that the device was repaired, and the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.
 
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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 Key18877580
MDR Text Key337358690
Report Number2518422-2024-13232
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public(01)00884838020054
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,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
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 V60PLUS VENTILATOR
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/17/2024
Initial Date FDA Received03/11/2024
Date Device Manufactured07/29/2019
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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