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

Model Number 0998-00-3013-53

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge authorized dealer engineer was dispatched to investigate.The engineer evaluated the iabp unit and connected the ac to confirm whether the power supply and indicator light were the problem.The engineer confirmed that the fans all worked normal and the ac can be turned on, and therefore, ruled out the power supply to be the cause of the issue.The engineer then removed the outer cover to confirm the operation of the internal circuit board, as well as the main board.However, the surrounding solenoid board, motor control board, and display board were not working.Despite replacing the main board, solenoid driver board and motor control board, but the issue persisted.The power supply fuse was measured confirming that one of the fuses was broken.After replacement of the broken fuse and restarting the unit, the issue was not resolved.The engineer then replaced the motor control board, cleaned the original motor control board and cross-tested the motor control board to discover that it was damaged.Repairs are ongoing a supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6) hospital.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) was unable to boot.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that during a routine inspection, performed by a getinge authorized dealer's field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) was unable to boot.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge service representative reported that the getinge authorized dealer's field service engineer that evaluated the iabp and attempted to fix the reported problem as mentioned in the initial emdr, replaced the motor control board, and the issue was corrected.All functional and safety checks to meet factory specifications were performed.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will e submitted upon completion of our investigation.The initial reporter named in block e1 is a getinge authorized dealer's field service engineer who has different contact details from that of the event site.A contact telephone number at the event site is (b)(6).

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected field: g1 (contact person ¿ mfg site).

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 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: 12561641
• MDR Text Key: 274277691
• Report Number: 2249723-2021-02218
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 10/13/2022
• Supplement Dates FDA Received: 11/08/2021; 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.