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

Model Number 0998-00-3013-68

Device Problem Unexpected Shutdown (4019)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient of the cs100 intra-aortic balloon pump (iabp) it had a shutdown.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Type of investigation not yet determined: additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.The full event site name is (b)(6).

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was able to reproduce the reported issue.The anomaly was detected when the equipment was started for the first time.In subsequent tests no anomalies were found.The on/off button faulty.The on/off button was replaced to resolve the issue.The tests to check the operation of the on/off button.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The equipment not released for clinical use because a long trial is required.The confirmation of support for release for clinical use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 12796054
• MDR Text Key: 280778361
• Report Number: 2249723-2021-02600
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: 10607567107691
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/1999
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.