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

Model Number CS100

Device Problems Device Emits Odor (1425); Battery Problem (2885); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2011

Event Type  malfunction  

Event Description

The customer reported that while the unit was staged in the cath lab, charging from an ac outlet, they noticed a bad smell coming from the unit.No patient was involved.

Manufacturer Narrative

The company representative observed that the dc power was not working.The company representative observed that the batteries were not charging and was emitting a bad smell.It was also noticed that the iabp wouldn't run on batteries but would run on ac power.The company representative replaced the power supply (part number 0014-00-0033e05), and batteries (part number 0146-00-0039).The company representative performed functional tests, electrical safety checks, calibration and full preventive maintenance including replacement of the safety disk (part number 0997-00-0985-01).The unit met factory specification was 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: 4012748
• MDR Text Key: 16542282
• Report Number: 2249723-2014-00906
• 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: 03/22/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• 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: 03/22/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2004
• 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