MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100,ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Backflow (1064)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp) unit had a blood back event.

Manufacturer Narrative

Updated fields - b4,d9,e1(site country),e2,e3,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, investigation conclusions),h10,h11.Corrected field : (d1 - brand name), (d4 - version or model #, catalog #,unique identifier (udi) #),d5,g2.Additional information - e1 (event site postal code - 1780).Additional information was requested from the customer with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.H3 other text : no information available.

Event Description

N/a.

• Brand Name: CS100,ENGLISH,NON-UTS,INTL
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15279549
• MDR Text Key: 305349417
• Report Number: 2249723-2022-02145
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 02/24/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1