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 Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was requested by customer for a technical visit of the cardiosave intra-aortic balloon pump (iabp) is believed to have a problem with the power supply.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h10.Additional info: e1 (event site state: mg, event site postal code: 30110-934).Customer requests a technical visit to inspect the equipment, she believes that the equipment has a problem with the power supply.They sent a proposal for approval, as the equipment is not included in a maintenance contract.A getinge field service engineer (fse) says service will be provided as soon as the proposal is approved and fse will open as a new complaint.There is no information available about part replaced or not.Patient involvement is unknown.H3 other text : repair service not done yet.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).

• 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: 19072620
• Report Number: 2249723-2024-01468
• Device Sequence Number: 4682752
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117(21)2325-B5
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/27/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 01/27/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/15/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown