MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an emergency case late, after pci was completed, the patient was being managed in the emergency department on the cardiosave intra-aortic balloon pump (iabp) unit when the emergency department contacted the ominato ce, who said that although it was ac-powered, for some reason it was running on battery power and was showing 25 minutes remaining, so the balloon was replaced with another pump in the hospital and treatment continued.The ominato ce returned to the ce center, plugged it into an outlet and charged it for about three hours, but when he returned and tried to turn it on, it would not turn on.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d4(version or model #, catalog #, serial#, unique identifier (udi) #), g3, g6, h2, h10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, e1 initial reporter, e2, e3, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component code), h11.Corrected fields: b5.A getinge field service engineer (fse) evaluated the unit and was able to reproduce the reported malfunction.The fse replaced the ac power cord reel after finding a broken cable.The fse also replaced the power supply, o-ring, and the special seal.Operation results were good.
Event or Problem Description
It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) was running on ac, but switched to battery power.The remaining charge showed only 25 minutes remaining.The hospital replaced the pump and treatment was resumed.The malfunctioning unit was placed into an outlet and was charged for about three hours.When the customer attempted to turn the unit on, it would not.There was no harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6, h11.Corrected fields: g2.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (health effect ¿ impact codes).
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE J PLUG
• 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: 19775173
• Report Number: 2249723-2024-02877
• Device Sequence Number: 20996486
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117(21)CA234855I3
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112372
• 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,Followup,Followup
• Report Date (Section B): 07/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 02/17/2025; 06/18/2025; 06/27/2025; 07/03/2025
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 11/07/2024; 02/18/2025; 06/25/2025; 06/27/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown