• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MONITOR,BP,WRIST,DIGITAL UNIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDLINE INDUSTRIES INC. MONITOR,BP,WRIST,DIGITAL UNIT Back to Search Results
Catalog Number MDS4003
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that the end-user received inaccurately elevated blood pressure (bp) readings. The end-user was instructed to take additional bp medication for elevated blood pressure readings by her physician. The end-user took additional bp medication for the bp readings that were received. No serious injury, additional medical treatment, or follow-up care reported. The sample was returned to the manufacturer for evaluation. The sample inflated and deflated as intended and the blood pressure readings were within normal blood pressure measurements when compared with readings from a control bp monitor. The reported inaccurate elevated bp readings were not reproduced. The reported product issue was not confirmed. A root cause could not be determined. Due the need for medical intervention to treat the inaccurate elevated bp readings, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that the end-user received inaccurately elevated blood pressure (bp) readings and took additional bp medication.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceMONITOR,BP,WRIST,DIGITAL UNIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key7833421
MDR Text Key118888196
Report Number1417592-2018-00098
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00888277675493
UDI-Public00888277675493
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMDS4003
Device Lot Number07518040001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/30/2018 Patient Sequence Number: 1
-
-