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

Model Number	0998-00-0800-36
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions, event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine check, cardiosave intra-aortic balloon pump (iabp) was showing battery failure.There was no harm or injury reported.
Additional Manufacturer Narrative
Due to character restrictions in e1: full initial reporter name: (b)(6).Updated fields: b4, b5, b6, b7, d9, d10, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.
Event or Problem Description
It was reported that during routine check, cardiosave intra-aortic balloon pump (iabp) was showing battery failure.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6.Corrected fields: h11.A getinge field service engineer (fse) performed a battery test but battery maintenance message persisted.During the inspection, it was also identified that the security disk had reached its usage cycle limit, generating a second alert message on the equipment.Fse replaced the battery (0146-00-0097) and the safety disk (0202-00-0140).Functionality tests were performed, and no errors were identified during validation.The equipment is compliant and cleared for use.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: h6 (health effects - impact codes).

• Brand Name: CARDIOSAVE HYBRID - TYPE "N" 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23300848
• Report Number: 2249723-2025-0004315
• Device Sequence Number: 20049645
• Product Code: DSP
• UDI-Device Identifier: 10607567114187
• UDI-Public: (01)10607567114187
• 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,Followup
• Report Date (Section B): 12/30/2025

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: 0998-00-0800-36
• Device Catalogue Number: 0998-00-0800-36
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 12/30/2025; 12/30/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/30/2025; 12/30/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: H6 (HEALTH EFFECTS - IMP
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.; UNKNOWN.
• Patient Sex: Unknown