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

Model Number JPD-900W

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: DRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
• MDR Report Key: 8358941
• MDR Text Key: 137171615
• Report Number: MW5084168
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 06951740514514
• UDI-Public: 06951740514514
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JPD-900W
• Device Lot Number: 1806-02-10000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68