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 No Audible Alarm (1019)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The customer has not requested getinge to evaluate the iabp in connection with this event.They replaced the solenoid driver board.The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that during preventive maintenance (pm) performed by the customer claims that the cs300 intra-aortic balloon pump (iabp) did not alarm during the blood back sensor test.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.

Event Description

It was reported that during preventive maintenance (pm) performed by the customer claims that the cs300 intra-aortic balloon pump (iabp) did not alarm during the blood back sensor test.There was no patient involvement, and no adverse event reported.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9978131
• MDR Text Key: 193056366
• Report Number: 2249723-2020-00649
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1