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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 PLUS
Device Problem Smoking (1585)
Patient Problem No Information (3190)
Event Date 05/08/2020
Event Type  malfunction  
Event Description
Reportedly, on (b)(6) 2020, after the power was plugged in and turned on, the programmer was smoking.The screen did not light up, the power key was green, and the screen remained black when pressing any key.Pressing the shutdown key cannot shutdown the device.It is not possible to fully investigate the root cause of the reported event because the programmer was repaired beforehand.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Reportedly, on (b)(6) 2020, after the power was plugged in and turned on, the programmer was smoking.The screen did not light up, the power key was green, and the screen remained black when pressing any key.Pressing the shutdown key cannot shutdown the device.It is not possible to fully investigate the root cause of the reported event because the programmer was repaired beforehand.
 
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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 Key10117937
MDR Text Key194449791
Report Number1000165971-2020-00412
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 consumer
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORCHESTRA PLUS
Device Catalogue NumberORCHESTRA PLUS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/08/2020
Event Location Hospital
Date Manufacturer Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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