CLINICAL INFORMATION CENTER

MDR report key: 2453214 · Received February 10, 2012

Report

Report Number: 2124823-2012-00031
Event Type: Death
Date Received: February 10, 2012
Date of Event: January 13, 2012
Report Date: January 13, 2012
Manufacturer: GE HEALTHCARE
Product Code: DXJ
PMA / PMN Number: K053356
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. (B)(6).

Description of Event or Problem · 1

THE HOSPITAL REQUESTED RECOVERY OF ECG STRIPS FOLLOWING A REPORTED PT DEATH. LOG FILES WERE REPORTEDLY RECOVERED AND SENT TO GE HEALTHCARE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CLINICAL INFORMATION CENTER	CENTRAL STATION	DXJ	GE HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death