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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 03/03/2024
Event Type  malfunction  
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 hcp was notified immediately, and irhythm learned that the hcp was already aware of the patient's arrhythmia and was treating it.There were no delays in treatment, and 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 Key19145790
MDR Text Key341134629
Report Number3007208829-2024-00182
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/19/2024
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Is the Device Single Use? No
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 Age82 YR
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