MAUDE Adverse Event Report: DATASCOPE CORP., CARDIAC ASSIST DIVISION CS100 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 01/18/2014

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2014, iab was inserted into a patient with ami and pumping was started with cs100.The me received a call from icu claiming that the iabp gave out a foul smell.The me found that the icu was filled with sulfurous odor (rather than burnt door) and it attributed to iabp fan.There was nothing wrong with pumping itself, but he immediately replaced the iabp with an alternative (sys98) to continue the therapy.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: 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.Service report: it was found that the cause was battery failure.Battery sealed lead acid 12v (d146-22-0039) x2 were replaced on (b)(4).After replacing them, our fse tested battery charging along with running.Also performed preventative maintenance based on our checklist, the iabp posed no problem.(b)(4).

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP., CARDIAC ASSIST DIVISION; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP., CARDIAC ASSIST DIVISION; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: janice pevide, mgr ; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4106569
• MDR Text Key: 16303983
• Report Number: 2249723-2014-00073
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2014
• 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
• Patient Outcome(s): Other