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

Model Number 0998-UC-3013-65 - CS100 JAPANESE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

E1 city : (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during regular inspection, the cs100 intra-aortic balloon pump (iabp) has caster damage.There was patient involvement.

Event Description

It was reported that during regular inspection, the cs100 intra-aortic balloon pump (iabp) has caster damage.There was no patient involvement.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18551976
• MDR Text Key: 333353733
• Report Number: 2249723-2024-00279
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: 10607567107684
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-UC-3013-65 - CS100 JAPANESE
• Device Catalogue Number: 0998-00-3013-65
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.