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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 Insufficient Information (3190)
Patient Problem Burning Sensation (2146)
Event Date 04/05/2019
Event Type  Injury  
Event Description
The subject holter was sent back for repair, because a burn of the size of the sensor was reportedly observed on the patient's chest.
 
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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
0146013665
MDR Report Key8623168
MDR Text Key145973250
Report Number1000165971-2019-00280
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSPIDERVIEW
Device Catalogue NumberSPIDERVIEW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/26/2019
Event Location Hospital
Date Manufacturer Received07/15/2019
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

Patient Treatment Data
Date Received: 05/20/2019 Patient Sequence Number: 1
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