MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problems Device Alarm System (1012); Appropriate Term/Code Not Available (3191)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) displayed system failure / low vacuum alarm intermittently.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device: the getinge service engineer reported that on (b)(6) 2021, the unit was tested.The service engineer found that the iabp had a problem with the drive manifold (part no: 0104-00-0018) which is defective.The repair has not been completed, awaiting for the customer's po.Additional information it 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.

Manufacturer Narrative

The getinge fse returned to the facility and replaced the manifold drive and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a routine check the cs100 intra-aortic balloon pump (iabp) displayed system failure / low vacuum alarm intermittently.There was no patient involvement and no adverse event was reported.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 12836544
• MDR Text Key: 280959052
• Report Number: 2249723-2021-02677
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

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: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/20/2021; 01/25/2023
• Supplement Dates FDA Received: 01/13/2022; 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1