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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 Problem Temperature Problem (3022)
Patient Problem No Information (3190)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
Reportedly, the subject device became hot when inserting 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
laura ouaki
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR   92140
146013429
MDR Report Key10231876
MDR Text Key198107229
Report Number1000165971-2020-00470
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2020
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 Manufacturer06/30/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/16/2020
Event Location No Information
Date Manufacturer Received09/03/2020
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 Unkown

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