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 Problems Device Sensing Problem (2917); No Pressure (2994)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported "not reading pressures" issue.The 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.The full event site name in is (b)(6) university.

Event Description

It was reported that prior to use it was observed that the cs300 intra-aortic balloon pump (iabp) was not reading pressures.There was no patient involvement, and no adverse event reported.

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: 14414861
• MDR Text Key: 291826065
• Report Number: 2249723-2022-01150
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

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: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1