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 Erratic or Intermittent Display (1182)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: at this time, the customer has not requested getinge to evaluate the iabp unit involved in this event.Attempts to communicate with the customer have been made to obtain further repair information.A supplement report will be submitted should additional information be provided.Device not returned to manufacturer.

Event Description

It was reported that during a routine check, a rental cs300 intra-aortic balloon pump (iabp) from agiliti had intermittent display issues upon power-up.It was also reported that the cs300 will be evaluated once returned to agiitii warehouse.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device (10): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit, and was unable to reproduce the reported issue.The fse performed a full preventive maintenance (pm) with all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1 (initial reporter name), e2, e3, g3, g6, h2, h4, h6, h10, h11.Corrected fields: e1 (telephone number), g1.Initial reporter's additional information: avp of cv services.

• 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: 12675713
• MDR Text Key: 278175810
• Report Number: 2249723-2021-02422
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1