MAUDE Adverse Event Report: GE HEALTHCARE CIC PRO; MEDICAL CATHODE-RAY TUBE DISPLAY

Device Problems Telemetry Discrepancy (1629); Improper Alarm (2951); Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

It was reported that the central station alarmed intermittently and displayed an error message that could only be resolved after restarting the system.Log files were requested from the hospital for eval.There was no reported consequence to the pt.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A f/u report will be submitted once the investigation has been completed.Under (b)(6) law, pt data is considered confidential and will not be released by the hospital.

• Brand Name: CIC PRO
• Type of Device: MEDICAL CATHODE-RAY TUBE DISPLAY
• Manufacturer (Section D): GE HEALTHCARE; milwaukee WI
• Manufacturer (Section G): GE HEALTHCARE; milwaukee WI
• Manufacturer Contact: james giles ; 3000 n. grandview blvd.; w450; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4210794
• MDR Text Key: 4965366
• Report Number: 2124823-2014-00016
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• 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?: No
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1