MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MONITOR,BP,AUTO,DIGITAL,ADULT

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.

• Type of Device: MONITOR,BP,AUTO,DIGITAL,ADULT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8540521
• MDR Text Key: 142793598
• Report Number: 1417592-2019-00055
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: MDS3001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/01/2019
• 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