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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM
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ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM Back to Search Results
Model Number 8700-0650
Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
Zoll has not yet received the thermogard console for evaluation.A supplemental report will be filed if and when the console is returned and investigation has been completed.
 
Event Description
The thermogard console (sn (b)(4)) displayed mid:04 (post int ram) error message upon power up.No patient involvement.
 
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Brand Name
ZOLL IVTM THERMOGARD XP
Type of Device
THERMAL REGULATING SYSTEM
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer Contact
kimthoa nguyen
2000 ringwood ave,
san jose, CA 95131
4084192922
MDR Report Key7661551
MDR Text Key113192182
Report Number3010617000-2018-00701
Device Sequence Number1
Product Code NCX
UDI-Device Identifier00849111075022
UDI-Public00849111075022
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072234
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8700-0650
Device Catalogue Number8700-0650
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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