MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID TYPE D PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-33
Medical Device Problem Codes	Charging Problem (2892); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other contact phone number: (b)(6)\ updated fields: b1, b4, g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions), h11 \ correction fields: d10, e1(event site name), e2, e3, g2, g7, h6(medical device problem code)\ revert a1,h4 should left blank\ a getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that upon checking the machine the mentioned issue was observed.The fse checked the machine and found no mains voltage on the power cord and power supply.The fse reported that the device was not showing the mains indicator and not charging the batteries as well.The fse mentioned that the reel ac power cord required replacement.After replacement the fse found that the mentioned failure was resolved.The fault logs were requested for review but were not provided by the customer.The unit passed all safety and functional checks successfully.The device was returned to the customer and cleared for clinical use.\ based on fse investigation the effect of power supply failure or power cord or plug stuck or unable to be pulled out or no ac power or damaged on the cardiosave is confirmed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11\ corrected field- g2.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site postal code: (b)(6).\ upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the fse that the cardiosave intra-aortic balloon pump (iabp) is not showing main supply.There was no patient involved.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the machine was checked and no mains voltages were detected on the power cord or power supply.Unit is not showing the mains supply indicator and not charging the batteries as well.Fse found that below mentioned spare are defective.Replaced the same and resolved the issue.\ device passed the all safety and functional checks successfully.Device was returned to customer and cleared for clinical use.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 50708896
• Report Number: 2249723-2026-0004234
• Device Sequence Number: 9852722
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown