MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-45

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp) screen was not bright/went black after turning on the device and the device was suspended.There was no patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Due to character restrictions in block e1 telephone number : (b)(6).

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp) screen was not bright/went black after turning on the device and the device was suspended.This was clarified as: turn on the ac power and it will show that the battery is in use.After the battery is used up, it will automatically shut down.There was no patient involved.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the cs100 intra-aortic balloon pump (iabp).The fse found that when the device was connected to ac power and turned on, the battery was being used and could not be charged.The power module is faulty.Customer informed of decision not to repair the device.

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 18065076
• MDR Text Key: 327279467
• Report Number: 2249723-2023-04725
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: 10607567107790
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 02/28/2024
• Supplement Dates FDA Received: 11/29/2023; 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1