MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse replaced the drive manifold and found the problem was the same.The fse checked the compressor unit and found that the diaphragm of compressor was damaged which was responsible for vacuum and pressure generation.To fix the issue, the 5000 hours maintenance kit must be replaced first.Further diagnosis could be done after replacement of the 5000 hours maintenance kit.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cs100 intra-aortic balloon pump (iabp) had a low vacuum error.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.

Manufacturer Narrative

Updated fields: a1, b4, b5, b6, b7, d11, e1 (event site email), e2, e3, g3, g4, g7, h2, h6 (health effect ¿ impact codes), h10.

Event Description

It was reported that prior to use, the cs100 intra-aortic balloon pump (iabp) had a low vacuum error.The unit alarmed for the reported issue.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Additional information poc: (b)(6) & event site state : (b)(6).

Event Description

N/a.

• Brand Name: CS100 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: 12972558
• MDR Text Key: 284524872
• Report Number: 2249723-2021-02817
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 01/19/2022; 02/24/2024
• Supplement Dates FDA Received: 02/11/2022; 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1