MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for DRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR JPD-900W manufactured by Shenzhen Jumper Medical Equipment Co., Ltd..
[137171615]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084168 |
| MDR Report Key | 8358941 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-10 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRKEA FULLY AUTOMATIC WRIST BLOOD PRESSURE CUFF MONITOR |
| Generic Name | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| Product Code | DXN |
| Date Received | 2019-02-19 |
| Model Number | JPD-900W |
| Lot Number | 1806-02-10000 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-19 |