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

Model Number CS100

Device Problem Device Emits Odor (1425)

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

Event Date 12/25/2013

Event Type  malfunction  

Event Description

The customer reported that while the iabp was in use on a patient, the iabp emitted a foul odor.The patient was switched to another iabp and therapy was continued.No patient injury was reported.

Manufacturer Narrative

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.The company representative observed that the batteries were deformed and leaking.The company representative replaced the batteries (part #0146-00-0039).The iabp was tested to factory specifications.It functioned normally and was returned to the customer.The batteries replaced are being sent to the manufacturing facility at (b)(4) for evaluation.A supplemental medwatch report will be submitted when additional information becomes available.(b)(4).

• Brand Name: CS100 INTRA-AORTIC PUMP
• 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, mgr. ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 3959708
• MDR Text Key: 4559819
• Report Number: 2249723-2014-01002
• 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,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• 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: 12/25/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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