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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TZ MEDICAL TZ MEDICAL INC. CLARUS 40M DETECTOR AND ALARM ARRHYTHMIA

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TZ MEDICAL TZ MEDICAL INC. CLARUS 40M DETECTOR AND ALARM ARRHYTHMIA Back to Search Results
Model Number 01 0 0811331 01153 1
Device Problems Device Alarm System (1012); Charging Problem (2892)
Patient Problem No Information (3190)
Event Date 08/16/2018
Event Type  Injury  
Event Description

Telemetry monitor needed recharge more often than 24 hours off monitor for charging 3 to 4 hours. Sometimes charging guide not working. Need to be at an electrical outlet to charge restricting time available to charge unit. Kept getting error messages, had to power off and restart to clear message. At one point these messages were happening at least called mobile cardiac monitoring regarding malfunction. They were unable to provide any advice on fixing problem. Today they are going to deliver a new device, 5 days later. (b)(4).

 
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Brand NameTZ MEDICAL INC. CLARUS 40M
Type of DeviceDETECTOR AND ALARM ARRHYTHMIA
Manufacturer (Section D)
TZ MEDICAL
portland OR
MDR Report Key7846416
MDR Text Key119358583
Report NumberMW5079561
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number01 0 0811331 01153 1
Device LOT Number21 H3R3300989
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/04/2018 Patient Sequence Number: 1
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