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

Model Number CS300

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2012

Event Type  malfunction  

Event Description

The customer reported that while the iabp was in use on a patient, the iabp started smoking.The smoke was noted by the patient and pointed out to the nurse in service that he could smell the smoke.The iabp was maintained by a third party.The patient was switched to another iabp and therapy was continued.No patient injury was reported.

Manufacturer Narrative

The company representative cleaned "inlet of power supply" to resolve issue with overheating power supply.The company representative performed full calibration, functional tests and safety checks.The iabp met factory specifications and was returned to the customer.(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 evancho1 ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4096290
• MDR Text Key: 4764038
• Report Number: 2249723-2014-01169
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/27/2012
• Initial Date FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• 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