FDA Adverse Event Malfunction Summary report: N

CS300

MDR report key: 3979735 · Received July 2, 2014

Report

Report Number: 2249723-2014-00975
Event Type: Malfunction
Date Received: July 2, 2014
Date of Event: January 24, 2011
Report Date: January 24, 2011
Manufacturer: DATASCOPE CORP
Product Code: DSP
PMA / PMN Number: K063525
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY REP REPLACED THE DISPLAY CONTROLLER BOARD (PART NUMBER 0670-00-0640E), DISPLAY CABLE CONNECTOR (PART 0012-00-1058), IV POLE SHAFT COLLAR (PART NUMBER 0105-00-0114), BUSHING POLE MOUNT (PART NUMBER 0358-00-0063) WERE REPLACED. EXPIRED SAFETY DISC ASSEMBLY (PART NUMBER 0997-00-0985-01), BRACKET LOCKING CART (PART NUMBER 0406-00-0860), LATCH CONSOLE RELEASE CART (PART NUMBER 0367-00-0091) AND SCREW SHOULDER (PART NUMBER 0212-00-0096) WERE REPLACED. THE COMPANY REP PERFORMED PNEUMATIC PERFORMANCE SERVICE DIAGNOSTICS, FUNCTIONAL TESTS, ELECTRICAL SAFETY CHECKS, CALIBRATION AND FULL PREVENTIVE MAINTENANCE. THE IABP MET FACTORY SPECS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

Description of Event or Problem · 1

DURING A PREVENTIVE MAINTENANCE, THE COMPANY REP OBSERVED FLUID SPILL ON THE DISPLAY CONTROLLER BOARD AND ON THE DISPLAY CABLE CONNECTOR. IV POLE SHAFT COLLAR WAS FOUND BROKEN AND BUSHING POLE MOUNT WAS MISSING. THE HELIUM TANK GAUGE READING WAS 1852 PSI. NO PT WAS INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
387042	CS300	INTRA-AORTIC BALLOON PUMP	DSP	DATASCOPE CORP	CS300

Patients

Seq	Age	Sex	Outcome	Treatment
1