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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. DRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. DRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number JPD-900W
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Dizziness (2194)
Event Date 02/10/2019
Event Type  Injury  
Event Description
I used an automatic wrist bp cuff made by drkea after coming home from a surgery with a blood loss of 900cc¿s, a low rbc, low bp and serious dehydration. I was told to watch my bp and drink as much as possible. If my bp stayed low i was to go to the hospital er if i had symptoms, ie: dizziness or fainting or stumbling. My bp was constantly 70¿s/50¿s. I was a bit tipsy and dizzy. After 3 days of rehydration, the bp remained very low. Instead of going to the hospital, because i felt fine at that point, i had a visiting nurse to the house and the next day a pt visit. Their bp measurement with a manual adult arm cuff, my bp was consistently 120/78. My husband bought an adult manual arm cuff and my bp has been fine at 120¿s/70¿s. I had not taken any cardizem for my bp as ordered to resume when bp stabilized after rehydration. Not to mention, my husband taking a day off from work, leaving the staff short and losing that day¿s pay.
 
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Brand NameDRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
MDR Report Key8358941
MDR Text Key137171615
Report NumberMW5084168
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJPD-900W
Device Lot Number1806-02-10000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1
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