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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS CPAP BREATHING MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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PHILIPS / RESPIRONICS, INC. PHILIPS CPAP BREATHING MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Hemoptysis (1887); Vomiting (2144); Choking (2464)
Event Date 01/01/1990
Event Type  Injury  
Event Description
Spitting up blood, choking in morning, mucus so bad he throws up.Started philips cpap machine in 1990's and started having all these negative symptoms in 2003.
 
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Brand Name
PHILIPS CPAP BREATHING MACHINE
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key13289635
MDR Text Key284147446
Report NumberMW5106744
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/18/2022
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 Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/18/2022
Patient Sequence Number1
Treatment
B-13 FOR WEIGHT LOSS; CARVEDILOL ; PANTOPRAZOLE ; XARELTO
Patient Outcome(s) Hospitalization; Required Intervention; Other; Disability; Life Threatening;
Patient Age62 YR
Patient SexMale
Patient Weight159 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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