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

Model Number CS100

Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2011

Event Type  malfunction  

Event Description

The customer reported that while the iabp was in use on a pt during transfer, when the plug was inserted into the ambulance power socket, a burnt odor began to smell and then there was an explosive noise from inside the iabp.Pumping was not affected.After weaning the pt from the iabp, they were unable to turn the iabp back on.When the event occurred, all equipment in the car was turned off.They believe the pump was running on battery.No pt injury was reported.

Manufacturer Narrative

The company rep could not turn the pump on, when the iabp's ac plug was plugged in to the ac outlet.The company rep checked the power supply and found the leakage of electrolyte of the electrolytic capacitor.The company rep speculated that the supply voltage supplied from the ambulance inverter varied beyond the permissible range of the electrolytic capacitor of the pump and the electrolytic capacitor was destroyed.The pump was repaired and returned to the customer.(b)(4).

• Brand Name: CS100
• 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: 4004930
• MDR Text Key: 4709863
• Report Number: 2249723-2014-00992
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• 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: 06/30/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 06/30/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• 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