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

Model Number CS100

Device Problems Device Emits Odor (1425); Device Inoperable (1663)

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

Event Date 03/13/2014

Event Type  malfunction  

Event Description

The customer reported that at 3:00 am, cabg operation was performed with iabp for a hospitalized patient who had hemodynamic compromise.At 4:00 am, the customer smelled like a burning odor so replaced the iabp.No pt injury was reported.At 8:00 am, medical engineers of the hospital investigated the iabp and found that the fan of the power supply unit was not revolving.In addition, the iabp was working with battery despite it being connected to ac power.

Manufacturer Narrative

The company service engineer evaluated the device and the power supply unit (p/n 0014-00-0033-05) was replaced and the iabp unit was returned to the customer.The device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.(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, manager ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 3897576
• MDR Text Key: 4545092
• Report Number: 2249723-2014-00479
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 03/13/2014
• 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