MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/17/2019

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4). Device not returned.

Event Description

It was reported that "electrical fail code #35" occurred during initial operation since first installation of the cs100 intra-aortic balloon pump (iabp) on (b)(6) 2019. There was no service activity other than the removal of the pcb board and the datasette, and currently no additional errors are occurring. However, the root cause of the first error could not be explained to the user. Subsequently, on (b)(6) 2019, the iabp(intra-aortic balloon pump) was connected to a patient and the failure (electrical test fails code #35) of the iabp(intra-aortic balloon pump) prevented the iabp(intra-aortic balloon pump) from being used to treat the patient and the patient eventually died for other reasons; it was not related to the iabp(intra-aortic balloon pump) error. This report is for the balloon which had no reported malfunction.

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 9166969
• MDR Text Key: 161555718
• Report Number: 2248146-2019-00783
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 09/22/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/08/2019 Patient Sequence Number: 1