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 Electrical /Electronic Property Problem (1198)

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) failed battery runtime test.There was no patient involvement.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the c300 intra-aortic balloon pump (iabp) failed battery runtime test.There was no patient involvement.

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11 corrected data: b5,d1(blank,),d4( model, catalog, version, udi, revert to blank), g4,510k).

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue replaced the batteries.The fse performed a complete pm with full calibration.The unit passed all functional and safety checks per factory specifications.The iabp was then returned to the customer and cleared for clinical use.

• 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: 15106794
• MDR Text Key: 304603074
• Report Number: 2249723-2022-01875
• 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: 08/03/2023

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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 05/19/2023; 08/03/2023
• Supplement Dates FDA Received: 05/31/2023; 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1