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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT SYSTEM MEDICAL MAGNETIC TAPE RECORDER

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IRHYTHM TECHNOLOGIES, INC ZIO AT SYSTEM MEDICAL MAGNETIC TAPE RECORDER Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2018
Event Type  Malfunction  
Event Description

A false positive af report was generated for the patient. The incorrect ecg report was delivered to the physician for interpretation; however the patient did not receive any therapy.

 
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Brand NameZIO AT SYSTEM
Type of DeviceMEDICAL MAGNETIC TAPE RECORDER
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC
650 townsend
suite 500
san francisco CA 94103
Manufacturer (Section G)
IRHYTHM TECHNOLOGIES, INC
650 townsend
suite 500
san francisco CA 94103
Manufacturer Contact
rich laguna
650 townsend
suite 500
san francisco, CA 94103
4156325701
MDR Report Key7780712
MDR Text Key117165935
Report Number3007208829-2018-00024
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/02/2018
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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