MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

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

Patient Problem Death (1802)

Event Date 04/01/2020

Event Type  Death  

Manufacturer Narrative

(b)(6). The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. Complaint record id # (b)(4).

Event Description

It was reported that during use on a patient, the display on the cs100 intra-aortic balloon pump (iabp) turned black, a long beep sounded and it stopped working. The iabp machine was used on a patient on the afternoon of (b)(6) 2020, during which time the machine was working normally. At about 18:50 pm on (b)(6), the screen suddenly turned black and a long beep sounded, and it failed to work. After several attempts to shut down and restart, the fault could not be ruled out. It was later reported that patient death had occurred on (b)(6) 2020. There was no reported malfunction on this report of the intra-aortic balloon(iab).

• Brand Name: LINEAR 7.5 FR. 40CC
• 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: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 9977352
• MDR Text Key: 188213677
• Report Number: 2248146-2020-00232
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K041281
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000104997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/20/2020 Patient Sequence Number: 1

Treatment

CS100 SA296547B9