CARDIOSAVE

Report

Report Number: 2249723-2014-00406
Event Type: Injury
Date Received: April 17, 2014
Date of Event: January 28, 2013
Report Date: January 28, 2013
Manufacturer: DATASCOPE CORP.
Product Code: DSP
PMA / PMN Number: K112372
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

SALINE SPILL ON UNIT CAUSED BOOT UP PROBLEM IN DIAGNOSTIC AND NORMAL MODE. THE SERVICE TECHNICIAN DISMANTLED INTERNAL PARTS, CLEANED UNITS PENETRATION OF SALINE PCB/S, CABLES, CONNECTORS, AND METAL SEAMS REASSEMBLED, CHECKED ERROR LOGS, VERIFYING AND REPLACING AFFECTED BOARDS, POWER SUPPLY, & AC CORDS TO GET UNIT TO BOOT UP. FULL DIAGNOSTICS, FUNCTIONAL TESTS AND CALIBRATION OF THE UNIT CHECKED OKAY. THE UNIT WAS PUT BACK INTO SERVICE. LIST OF PARTS REPLACED: PART NUMBER: D670-00-0768, DESCRIPTION: PCBA, BACKPLANE; D670-00-0765, PCBA, MOTOR CONTROL; D670-00-0766, PCBA, SOLENOID CONTROL; D670-00-0769, PCBA, FRONT END; D670-00-0770, PCBA, EXEC PROCESSOR; D670-00-0821, PCBA POWER SUPPLY MONITOR; D682-00-0092-01, PRESS XDCR HI PRESS 3500 PSIG; D014-00-0255, POWER SUPPLY, 4002 15V OUT; D997-00-0582, ASSY, PATIENT INTERFACE MODULE; D004-00-0103-02, TUBING ASSY, HELIUM, MULTIPLE. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT WILL NOT WORK, THE IABP WAS GENERATING A HIGH PITCH SOUND ON THE STAR-UP AND CIRCLE WAS GOING AROUND ON THE SCREEN. THE CUSTOMER TRIED TO REBOOT THE IABP, INSTRUCTED OVER THE PHONE BY A COMPANY REPRESENTATIVE, BUT DID NOT SOLVE THE PROBLEM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
235552	CARDIOSAVE	INTRA-AORTIC BALLOON PUMP	DSP	DATASCOPE CORP.	CARDIOSAVE

Patients

Seq	Age	Sex	Outcome	Treatment
1