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

Model Number 0998-00-3013-55

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that before use the cs100 intra-aortic balloon pump (iabp) was continuously alarming with an electrical test fail#91 and #99.There was no patient involvement.

Manufacturer Narrative

Additional information: e1 (event site postal code-(b)(6) ).It was reported that before use the cs100 intra-aortic balloon pump (iabp) was continuously alarming with an electrical test fail #91.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He checked the machine and found electrical test fail #91 coming continuously.This error is comes due to front end board so he need front end board for further check the machine.He replaced the front end board pcb then check the machine, machine is working ok.All pneumatic tests are passed.All parameters and functions are working properly.Handover the machine to user in good working condition.

Event Description

It was reported that before use the cs100 intra-aortic balloon pump (iabp) was continuously alarming with an electrical test fail#91.There was no patient involvement.

• Brand Name: CS100 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: 14854339
• MDR Text Key: 303072948
• Report Number: 2249723-2022-01511
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.