MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-57
Medical Device Problem Codes	Premature Discharge of Battery (1057); Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use on patient the cs300 intra-aortic balloon pump (iabp) equipment displays an alarm due to power disconnection and does not record it in the error log.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the physical state of the equipment is verified, the equipment is turned on and the log of alarms and events is verified from the service menu without finding any error message indicating power failure or low battery level.Additionally, it is verified that the console time agrees with the current time.The fse informed the staff, if they want to know the state of the batteries, they must carry out the factory test in which they must leave the battery charging without using the equipment for more than 8 hours, then the test is done from the service menu.The service menu is entered to perform a battery test, without being able to start the test, the batteries do not have enough charge despite lasting charging all weekend, simulator and balloon tests are carried out, detecting that the equipment lasts on against pressing 21 minutes, charging voltage is verified without finding anything new, it is suggested to change two backup batteries.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during use on patient the cs300 intra-aortic balloon pump (iabp) equipment displays an alarm due to power disconnection and does not record it in the error log , patient was admitted to the hemodynamic rooms with pop angioplasty of the anterior descending artery due to acute myocardial infarction with st segment elevation.At the time of the transfer the balloon control console ran out of battery when entered in the intensive care unit.The console was connected during the entire procedure which taken approximately one hour and twenty minutes before leaving the room, the battery charge of the console was checked which was above seventy percent.The procedure is carried out successfully.When turning the console off n the intensive care unit , the patient takes less than one minute without assistance and however hemodynamically unstable patient , enters cardiorespiratory arrest, resuscitation maneuvers are performed and patient is returned to circulation after two minutes of resuscitation.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V
• Common Device Name: 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: 17077492
• Report Number: 2249723-2023-02691
• Device Sequence Number: 6346266
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: 10607567108254
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2023

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: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• 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: 05/27/2023
• Supplement Date Received by Manufacturer: 06/09/2023; 10/04/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/23/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2017
• 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