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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER Back to Search Results
Model Number ORCHESTRA
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2018
Event Type  malfunction  
Event Description
Reportedly, the programmer does not initialize and the following message is displayed: operating system not found.Preliminary review indicates an issue with the hard disk drive that may be damaged or unplugged.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reportedly, the programmer does not initialize and the following message is displayed: operating system not found.Preliminary review indicates an issue with the hard disk drive that may be damaged or unplugged.
 
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Brand Name
ORCHESTRA
Type of Device
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key7308813
MDR Text Key101359428
Report Number1000165971-2018-00217
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/06/2018
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 Model NumberORCHESTRA
Device Catalogue NumberORCHESTRA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Distributor Facility Aware Date02/06/2018
Event Location Outpatient Diagnostic Facility
Initial Date Manufacturer Received 02/06/2018
Initial Date FDA Received03/02/2018
Supplement Dates Manufacturer Received04/06/2018
Supplement Dates FDA Received04/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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