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Catalog Number MDS3001
Device Problem High Test Results (2457)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 03/23/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that end user received a brand new automatic digital blood pressure monitor. Per report, new batteries were placed by the end user prior to using the device. Reportedly, the automatic blood pressure monitor was giving inaccurate high readings and end user remained taking her blood pressure medications. On (b)(6) 2019, the end user was taken to the hospital per emergency medical services and her blood pressure was 98/58. While in the hospital, the end user reportedly received intravenous fluids for 24 hours and no other medications were given. Tests performed were chest x-ray, bloodwork, ct scan of head, and an electrocardiogram. The results of these tests were not disclosed. The end-user was discharged and was instructed to measure correct blood pressure reading before taking blood pressure medications. Due to the reported hospitalization, this medwatch is being filed. The sample was returned for evaluation and the complaint of inaccurate high readings could not be confirmed. The readings were within the test settings and they showed normal function of the unit. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Event Description
It was reported that the automatic blood pressure monitor was giving inaccurate high readings.
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Manufacturer (Section D)
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8540521
MDR Text Key142793598
Report Number1417592-2019-00055
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 Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMDS3001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/23/2019 Patient Sequence Number: 1