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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

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SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
Model Number SPIDERVIEW
Device Problems Fluid Leak (1250); Overheating of Device (1437)
Patient Problem Insufficient Information (4580)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
Reportedly, the device became hot during the recording and battery leak was then observed. The inside of the device is dirty and damaged by the battery.
 
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Brand NameSPIDERVIEW
Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos
4 avenue réaumur
clamart, 92140
FR 92140
Manufacturer (Section G)
ASICA ZAC DE LA MOINERIE 35400 SAINT MALO FRANCE
parc d'affaires noveos
4 avenue réaumur
clamart, 92140
FR 92140
Manufacturer Contact
elodie vincent
parc d'affaires noveos
4 avenue réaumur
clamart, 92140
FR   92140
MDR Report Key12487241
MDR Text Key271887293
Report Number1000165971-2021-00646
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K032466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPIDERVIEW
Device Catalogue NumberSPIDERVIEW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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