MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-69

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cs100 intra-aortic balloon pump (iabp) helium cylinder handle and ground catheter support were absent.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

The (fse) reported that the helium cylinder handle and catheter support was missing.The unit passed all functional and safety tests.It is recommended by the factory that the items be replaced for full safe functioning of the equipment.The missing parts have not been replaced as customer has not approved po.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• 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: 18858459
• MDR Text Key: 337135759
• Report Number: 2249723-2024-00974
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: 10607567107769
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.