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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SCOTTCARE CORPORATION ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

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THE SCOTTCARE CORPORATION ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
Event Type  malfunction  
Event Description
The telemetry system in cardiac rehab was malfunctioning. Some (not all) cardiac monitors lost signal, and were not able to provide electrocardiogram tracings. This patient was unharmed.
 
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Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
THE SCOTTCARE CORPORATION
4791 west 150th st.
cleveland OH 44135
MDR Report Key11071827
MDR Text Key223611584
Report Number11071827
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2020
Event Location Hospital
Date Report to Manufacturer12/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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