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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIONET, INC EPATCH DETECTOR AND ALARM, ARRHYTHMIA

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CARDIONET, INC EPATCH DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Device Problem Data Problem (3196)
Patient Problem No Information (3190)
Event Type  Malfunction  
Event Description

Patient received a holter monitor. Epatch was registered to patient on cardionet. After receiving epatch at end of monitoring period, ekg technician was unable to upload patient's data to cardionet as the website stated patch was not retrievable. Tech called cardionet and was informed an i. T request was put in and they would contact back when issue was resolved. Cardionet never got back to department on status of the epatch. Manufacturer response for e-patch, epatch (per site reporter). Tech called cardionet and was informed an i. T request was put in and they would contact back when issue was resolved. Cardionet never got back to department on status of the epatch.

 
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Brand NameEPATCH
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
CARDIONET, INC
1000 cedar hollow road, suite 102
malvern PA 19355
MDR Report Key7888816
MDR Text Key120714811
Report Number7888816
Device Sequence Number1
Product Code DSI
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 08/23/2018,08/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2018
Event Location Hospital
Date Report TO Manufacturer09/19/2018
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?
Type of Device Usage

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