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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); Material Too Rigid or Stiff (1544)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2021
Event Type  malfunction  
Event Description
Reportedly, for at least two times with different battery brand (b)(6) and bovie batteries, both alkaline) the device overheated seriously in a way that it was almost impossible to touch. And one of the exam only lasted 18h and the slot of the battery was full of white substance released from the bovie battery (oxidation). With a third brand of battery (energizer), the overheating was not observed (or was at least not as noticeable). This recorder also does not memorize the date, it is difficult to have good impedances and any channel without noise. Hard buttons and color screen are also not appreciated.
 
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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 Key12639424
MDR Text Key276845557
Report Number1000165971-2021-00686
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K032466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
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 Manufacturer10/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? No
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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