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 Suction Problem (2170)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined: additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.The full name of the initial reporter that is abbreviated is (b)(6).

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a low vacuum alarm.The drive manifold assembly is in need of a replacement.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) had a low vacuum alarm.The drive manifold assembly is in need of a replacement.There was no patient involvement.

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue, replaced the drive manifold to resolve the issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.

• 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: 13593732
• MDR Text Key: 289501261
• Report Number: 2249723-2022-00393
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.