MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Failure to Power Up (1476)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) failed to power up. It is unknown the circumstances under which the event occurred. It is also unknown if there was a patient involvement. However, there was no adverse event reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11445781
• MDR Text Key: 240389877
• Report Number: 2249723-2021-00474
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2009
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Reuse