MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. PARADYM

Model Number PARADYM DR 8550

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Reportedly, when the patient file form follow-up performed on (b)(6) 2014 was opened, an error message stating "unable to read file" was displayed to the user.No follow-up data was available in this file.

Manufacturer Narrative

This event concerns a device that was manufactured and used outside the us.Analysis is pending.

• Brand Name: PARADYM
• 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 ; IT
• Manufacturer Contact: e. vincent ; parc d'affaires noveos; 4 avenue reaumur; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3784971
• MDR Text Key: 4439597
• Report Number: 1000165971-2014-00065
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2014,01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2012
• Device Model Number: PARADYM DR 8550
• Device Catalogue Number: PARADYM DR 8550
• Device Lot Number: 2507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1