MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-55

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: a supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp had a low vacuum level.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported prior to use that the cs300 intra-aortic balloon pump (iabp had a low vacuum level.There was no patient involvement.

Manufacturer Narrative

Updated sections: b4, g3, g6, g7, h2, h10, h11 corrected sections: b5, b6, b7, d4(udi #), d5, d10, e2, e3, h6(health impact code).

Manufacturer Narrative

Updated fields; b4, g3, g6, h2, h4, h6, h10, h11.Corrected fields; a1, d1, d4.A getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse replaced the drive manifold (0104-00-0018).Then, the fse verified that the unit was functioning correctly.The unit was then cleared for clinical use.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 12689358
• MDR Text Key: 278141437
• Report Number: 2249723-2021-02446
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 10/13/2022; 04/17/2023
• Supplement Dates FDA Received: 10/26/2022; 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1