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 Electrical /Electronic Property Problem (1198)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit is showing electrical code #50.There was no harm reported.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, g2, h6 (clinical and impact code).Updated data: b4, e1 (initial reporter and phone#), e2, e3, g3, g6, h2, h10, h11.

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) unit is showing electrical code #50.There was no patient involvement.

Manufacturer Narrative

Additional information: tel -(b)(6) & e1(event site postal code - (b)(6)) it was reported that the cs300 intra-aortic balloon pump (iabp) showing electrical code #50.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Checked and found that machine 5k hours maintanance kit is defective and it needs to be replaced.Quote was submitted but customer is not willing to repair it as per their distributor.H3 other text : distributor performed repair.

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: 18372718
• MDR Text Key: 331105541
• Report Number: 2249723-2023-05414
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.