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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2024
Event Type  malfunction  
Event Description
Philips received a complaint by the customer on the v60 indicating that the proximal pressure sensor auto-zero failed.It was reported there was no patient involvement at the time the issue was discovered.The customer called in to report that the proximal pressure sensor auto-zero failed.A field service engineer (fse) went onsite and confirmed the reported issue.The fse then replaced the gas delivery system (gds) and confirmed the reported issue was resolved.The fse replaced the gds to resolve the reported issue.The device passed required performance verification tests per philips standards 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 Key18552809
MDR Text Key333364986
Report Number2518422-2024-03726
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public(01)00884838025776
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,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 Number1076716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2024
Initial Date FDA Received01/22/2024
Date Device Manufactured03/18/2021
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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