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

Model Number	0998-00-3013-69
Medical Device Problem Codes	Premature Discharge of Battery (1057); Obstruction of Flow (2423); Power Problem (3010)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) has a power supply issue.The patient was in bed.It presents alarm in monitoring, the intraortic balloon (iabp) was disconnected.Iab placed in another socket, and it returns with interference on the screen regarding maintenance.Due to the incident, the patient is responsive.At 2 am patient worsens to crp, cpr maneuvers begin.Pulse present and stopped chest compression maneuvers, continued receiving noradrenaline 50ml, and initiated post-pcr procedures.The battery did not charge after the device was turned off.The patient was transferred to another location and another iabp.The patient was reported as stable as of follow up 2 weeks after the event.
Additional Manufacturer Narrative
Updated.
Event or Problem Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) has a power supply issue.The patient was in bed.It presents alarm in monitoring, the intra-aortic balloon (iabp) was disconnected.Iab placed in another socket, and it returns with interference on the screen regarding maintenance.Due to the incident, the patient is responsive.At 2 am patient worsens to crp, cpr maneuvers begin.Pulse present and stopped chest compression maneuvers, continued receiving noradrenaline 50ml, and initiated post-pcr procedures.The battery did not charge after the device was turned off.The patient was transferred to another location and another iabp.The patient was reported as stable as of follow up 2 weeks after the event.Additional information received on 18nov2024 stated: the patient is stable, patient was transferred to another location and another iab device, user contribute causality to the pump for the serious injury.The cpr maneuver began and 2 cycles with orotracheal intubation performed.Dr.Renato requests collection of stop gas with replacement of bicarbonate, which evolved to 3 cycles in asystole, pulse present and chest compression maneuvers interrupted.The device started operating in battery mode, after hours of use it ended up turning off due to lack of electrical power.
Additional Manufacturer Narrative
Updated fields: h6 (type of investigation, component codes, investigation findings, investigation conclusion).A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse stated that the batteries were okay but replaced as a precaution (0146-00-0039 x2).Several operation tests were performed, and the equipment did not show any abnormalities.The iabp was released for use.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20538725
• Report Number: 2249723-2024-0004390
• Device Sequence Number: 8324835
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 01/27/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/19/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown