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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. REPLY
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SORIN GROUP ITALIA S.R.L. REPLY Back to Search Results
Model Number REPLY DR
Device Problems Unable to Obtain Readings (1516); Failure to Transmit Record (1521)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/13/2014
Event Type  malfunction  
Event Description
During the follow-up performed on (b)(6) 2014, it was noticed that there was no data store in device memories.An explanation is requested.
 
Manufacturer Narrative
This event concerns a device that was manufactured and used outside the us.Analysis is pending.
 
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Brand Name
REPLY
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
saluggia vc
IT 
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
via crescentino s.n.
saluggia vc 1304 0
IT   13040
Manufacturer Contact
e. vincent
parc d'affaires noveos
4 avenue reaumur
clamart cedex 92140
FR   92140
46013687
MDR Report Key3784975
MDR Text Key4434399
Report Number1000165971-2014-00055
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P950029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/07/2014,01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2013
Device Model NumberREPLY DR
Device Catalogue NumberREPLY DR
Device Lot Number2543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 01/16/2014
Initial Date FDA Received02/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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