MAUDE Adverse Event Report: DATASCOPE CORP CS300; INTRA-AORTIC BALLOON PUMP

Model Number CS300

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Loss of Power (1475); Failure to Power Up (1476); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 06/04/2012

Event Type  malfunction  

Event Description

During the incoming inspection in tsc, system error occurred with abnormal noise, and the system shut down.Once rebooted, the display doesn't boot up and a bad smell occurs.Ic of keypad controller pcb has burned out.

Manufacturer Narrative

The service technician at the (b)(4) office replaced the assay display cs300 (part numb 0997-00-0524), overlay main keypad (b)(4) (part numb 0330-00-0039-06), label, main display, (b)(4) (part numb 0334-00-1638-06) on (b)(4) 2012.The unit was tested and functioned as expected.The replaced components were returned to (b)(4).The complaint of 'a system error occurred with abnormal noise, and the system shut down; once rebooted, the display doesn't boot and a bad smell occurs' was reproductible.Ic of keypad controller pcb has burned out.The c28 on the 0670-00-1145 keypad controller board had burnt up.Ths was the cause of the bad smell.In addition, component d4 was shorted.These components are part of the +12v supply that operated dc/ac inverter for the display.C28 probably shorted out which caused d4 to short out shutting down the +12v.A root cause of the component failure cannot be determined because c28 was so badly damaged.A new keypad controller was installed into the display head assembly and was powered up for one week with no problem, which indicates that no other components in the display head caused the keypad controller to fail.(b)(4).

• Brand Name: CS300
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: tina evancho ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 3902596
• MDR Text Key: 4541607
• Report Number: 2249723-2014-00509
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS300
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1