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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOE MEDICAL, INC. ULTRAVIEW DM3 PATIENT PHYSIOLOGICAL MONITOR

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ZOE MEDICAL, INC. ULTRAVIEW DM3 PATIENT PHYSIOLOGICAL MONITOR Back to Search Results
Model Number 91330
Device Problem Flare or Flash (2942)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2020
Event Type  malfunction  
Event Description
End-user reported that the device was at the nurses station and was no longer on a patient, but it was on and it was not plugged into the wall, when it started smoking and flaming. The fire was extinguished and the device was moved outside. Patients were moved out of the ward as a precaution due to the smell from the device. The likely cause of the fire was a thermal runaway in one of the battery cells. The cause of the thermal runaway is unknown at this time.
 
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Brand NameULTRAVIEW DM3
Type of DevicePATIENT PHYSIOLOGICAL MONITOR
Manufacturer (Section D)
ZOE MEDICAL, INC.
460 boston street
topsfield MA 01983
Manufacturer Contact
jim chickering
460 boston street
topsfield, MA 01983
9788871410
MDR Report Key11089303
MDR Text Key224124298
Report Number3003294644-2020-00002
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number91330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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