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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 Blocked Connection (2888)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2023
Event Type  malfunction  
Manufacturer Narrative
E1: reporting institution phone: (b)(6).Reporter phone number: (b)(6).
 
Event Description
Philips received a complaint from the customer on the v60 indicating that a 1201 "patient circuit occluded" alarm error occurred.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.Additionally, the device was swapped out for another ventilator.The investigation is ongoing.
 
Manufacturer Narrative
Per a good faith effort (gfe) response, the technician could not duplicate the 1201 error code, and no fault was found.No further information will be obtained.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired, a new service order will be opened and will be captured through philip's normal complaint procedure.
 
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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 Key17487727
MDR Text Key320693102
Report Number2518422-2023-19079
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838033832
UDI-Public00884838033832
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,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 Operator Health Professional
Device Model NumberV60
Device Catalogue Number1076709
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2023
Initial Date FDA Received08/09/2023
Supplement Dates Manufacturer Received08/15/2023
Supplement Dates FDA Received08/17/2023
Date Device Manufactured09/09/2019
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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