MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 2000; INTERVENTIONAL FLUOROSCOPIC X-RAY

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

The customer reported the radiation shield broke off at the extension arm.There was no reported injury associated with this event.

Manufacturer Narrative

Patient data not currently available.A follow-up report will be submitted when the investigation is complete.

• Brand Name: INNOVA 2000
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere bp 34; buc cedex 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere bp 34; buc cedex ; FR
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy.; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4239101
• MDR Text Key: 22165039
• Report Number: 9611343-2014-00075
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1