FDA Adverse Event Malfunction Summary report: N

CS100

MDR report key: 3261784 · Received July 30, 2013

Report

Report Number: 2249723-2013-00071
Event Type: Malfunction
Date Received: July 30, 2013
Date of Event: June 12, 2013
Report Date: June 12, 2013
Manufacturer: DATASCOPE CORP.
Product Code: DSP
PMA / PMN Number: K031636
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY REP DETERMINED THAT THE LCD BULB FAILED, CAUSING THE AC/DC INVERTER CIRCUIT AND VIDEO DRIVER PRINTED CIRCUIT BOARD TO FAIL. AS A RESULT, THE FOLLOWING COMPONENTS WERE REPLACED: DISPLAY W/RTV BEAD SEAL (PART NUMBER 0160-00-0113), PCB COLOR VIDEO RECEIVER (PART NUMBER 0670-00-0736), PCB INVERTER, DC TO AC (PAR NUMBER 0671-00-0230), CABLE VIDEO RECEIVER TO LCD (PART NUMBER 0012-00-1747), AND CABLE DC/AC INVERTER (PART NUMBER 0012-00-1428). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, THE IABP DISPLAY WAS DARK. THEY COULD NOT READ THE INFORMATION ON THE SCREEN. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356098	CS100	INTRA-AORTIC BALLOON PUMP	DSP	DATASCOPE CORP.	CS100	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI