MAUDE Adverse Event Report: DATASCOPE CORP CS100; INTRA-AORTIC BALLON PUMP

Model Number CS100

Device Problems Device Inoperable (1663); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2013

Event Type  Injury  

Event Description

The customer reported that while the iabp was in use on a patient, the iabp did not work due to missing ekg cables.The patient was switched to another iabp and therapy was continued.No patient injury was reported.

Manufacturer Narrative

After the customer placed the patient on another pump the company representative provided telephonic troubleshooting support to the customer biomed representative for the iabp in this complaint.The customer biomed used a simulator with a catheter, went over the initial set up and everything went smoothly.The customer biomed concluded that there was nothing wrong with the pump.The company did not evaluate the iabp because the customer did not require a service technician to evaluate the repair of iabp.The customer placed the iabp back into service.(b)(4).

• Brand Name: CS100
• Type of Device: INTRA-AORTIC BALLON 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 drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 3872027
• MDR Text Key: 4570861
• Report Number: 2249723-2014-00520
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS100
• Device Catalogue Number: 0998-00-3013-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2013
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other