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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2012

Event Type  malfunction  

Event Description

The customer reported that while the iabp was in use with a patient, a "foul smell" came from the iabp.The procedure was completed using the same iabp.No patient injury was reported.

Manufacturer Narrative

The company representative confirmed the foul smell from the iabp and found the leaking battery on the iabp.The batteries (part number 0146-00-0039) and grommet (part number 0348-00-0012) were replaced.The company representative verified that the batteries were charging properly and performed functional and safety tests.The iabp functioned normally and was returned to the customer.The original batteries were not provided by (b)(4), and had been replaced by the customer's biomed couple of years before and were due to be replaced in june 2012.(b)(4).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: 4093222
• MDR Text Key: 4759616
• Report Number: 2249723-2014-01173
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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: 05/22/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2003
• 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