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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 Tidal Volume Fluctuations (1634)
Patient Problem Low Oxygen Saturation (2477)
Event Date 04/09/2024
Event Type  Injury  
Manufacturer Narrative
H10: g: (b)(4).
 
Event Description
Philips received a complaint from the customer reporting the v60 ventilator alarmed with a low tidal volume and co2 rebreathing risk message.The patient experienced a desaturation of peripheral oxygenation to approximately 80%, prompting a device exchange.No further harm or injury was reported.Investigation is ongoing.
 
Manufacturer Narrative
A philips authorized service provider (asp) reported the customer contracted with a third-party service vendor for correction.The customer reported the problem was confirmed and the flow valve was replaced.The device was operational and returned to service after repairs were completed.The customer declined to provide further details.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
melissa rosko
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key19184378
MDR Text Key341072819
Report Number2518422-2024-22354
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public00884838025776
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
Reporter Occupation Physician
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2024
Initial Date FDA Received04/25/2024
Supplement Dates Manufacturer Received05/05/2024
Supplement Dates FDA Received05/07/2024
Date Device Manufactured09/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Life Threatening;
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