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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOOD PRESSURE MACHINE

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BLOOD PRESSURE MACHINE Back to Search Results
Device Problem High Readings (2459)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Patient called to report adverse events involving blood pressure machines being used in hospitals, doctor's offices, and clinics. Patient stated that the non-manual blood pressure machines being used do not correctly measure his blood pressure. Patient said the incorrect, high readings caused him to be put on blood pressure medication. Patient stated that the medication has left him paralyzed from the chin down. Patient said when his blood pressure is checked with a manual cuff, it's always within normal range. He said the machines have never read his blood pressure correctly. He is open to answering any questions or being interviewed to help resolve this issue.
 
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Brand NameBLOOD PRESSURE MACHINE
Type of DeviceBLOOD PRESSURE MACHINE
MDR Report Key6263097
MDR Text Key65452913
Report NumberMW5067314
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/18/2017 Patient Sequence Number: 1
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