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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problem Device Alarm System (1012)
Patient Problem Respiratory Arrest (4461)
Event Date 09/14/2020
Event Type  Injury  
Event Description
Patient removed bipap.Alarm did not transmit to the nurse call system despite being appropriately connected to the wall port.Tech found patient in respiratory arrest.Patient was intubated and upgraded to the intensive care unit.The patient was in a negative pressure room with an anteroom, making it difficult to detect the bedside alarm without the utilization of the nurse call system.
 
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Brand Name
PHILIPS RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct
carlsbad CA 92011
MDR Report Key10626340
MDR Text Key209777457
Report Number10626340
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/22/2020
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 No Information
Device Model NumberV60
Device Catalogue NumberU1053617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2020
Event Location Hospital
Date Report to Manufacturer10/05/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age27010 DA
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