MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Circuit Failure (1089)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), it was discovered that the cs300 intra-aortic balloon pump (iabp) solenoid driver board checks out of specifications.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that the solenoid driver board checks out of specification, reading out of range at tp2 (+) and tp5 (-) voltage.To fix the issue the fse removed and replaced the solenoid driver board which corrected the issue and all voltage readings are now in range, then performed all functional and safety checks to meet factory specifications.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 be submitted upon completion of our investigation.(b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Manufacturer Narrative

The faulty exch pcb, solenoid driver board was returned the national repair center(nrc) and inspected per procedure with no visual damage observed.The nrc installed the board into the cs300 test fixture and tested the board to factory specifications.The nrc verified the failure of the solenoid driver board voltage reading being out of specifications.The voltage reading observed was 1.33 volts.Factory specification is between 2.5 and 5 volts.The board failed testing.The nrc will send the board to the supplier for failure analysis per procedure.

Manufacturer Narrative

The national repair center installed the board into the cs300 test fixture and tested the board to factory specifications per the cs300 service manual revision v.The national repair center verified the failure of the solenoid driver board voltage reading being out of specifications.The voltage reading observed was 1.33 volts.Factory specification is between 2.5 and 5 volts.The board failed testing.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

• Brand Name: CS300 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: 13667295
• MDR Text Key: 286574428
• Report Number: 2249723-2022-00449
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 03/10/2022; 04/30/2024
• Supplement Dates FDA Received: 04/07/2022; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1