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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 Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Event Description
Reportedly, the subject device and the battery became hot.
 
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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 Key10828380
MDR Text Key215936944
Report Number1000165971-2020-00704
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 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
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 Manufacturer11/09/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/21/2020
Event Location No Information
Date Manufacturer Received04/02/2021
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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