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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZEUS SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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IRHYTHM TECHNOLOGIES, INC ZEUS SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Device Problem Inaccurate Information (4051)
Patient Problem Unspecified Heart Problem (4454)
Event Date 02/15/2024
Event Type  Injury  
Event Description
The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not communicated during the wear period.The investigation revealed that a preliminary ecg interpretation provided to the physician was misclassified.Following the wear period and while compiling the final report, the interpretation was amended.The healthcare provider (hcp) was immediately notified, and irhythm learned that the patient had received a pacemaker due to the initial interpretation.No further information was provided.
 
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Brand Name
ZEUS SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC
699 8th st suite 600
san francisco CA 94103
Manufacturer (Section G)
IRHYTHM TECHNOLOGIES, INC
6550 katella avenue, suite 200
cypress CA 90630
Manufacturer Contact
mazi kiani
699 8th st suite 600
san francisco, CA 94103
9494132147
MDR Report Key18965348
MDR Text Key338432056
Report Number3007208829-2024-00138
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K222389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2024
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received03/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ZIO AT/SN: (B)(6).
Patient Outcome(s) Other;
Patient Age94 YR
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