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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 Failure to Transmit Record (1521)
Patient Problem Unspecified Heart Problem (4454)
Event Date 01/03/2024
Event Type  malfunction  
Event Description
The patient experienced an arrhythmia that met medical doctor notification (mdn) requirements that was not transmitted during the wear period.The investigation revealed a potential algorithm sensitivity issue with the device.The healthcare provider (hcp) was immediately notified of the patient's arrhythmia.Despite several attempts to obtain more information, no additional details were obtained.No adverse events, such as death or serious injury, are known to have occurred.
 
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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 Key18703235
MDR Text Key336433981
Report Number3007208829-2024-00071
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 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/23/2024
Initial Date FDA Received02/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2023
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 Age62 YR
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