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

Model Number	0998-00-0800-35
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit gave an overheating error.They switch the pump off and back on again and it worked.For safety reasons, the customer was advised to switch out with another pump.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer(fse) was not dispatched to evaluate unit.More than three (3) gfe attempts have been performed to obtain additional information and/or product return.No response has been provided, the complaint will be closed and in the event new information and/or device was to become available, the file will be reopened and updated.A follow up mdr will be sent.
Event or Problem Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit gave an overheating error.They switch the pump off and back on again and it worked.For safety reasons, the customer was advised to switch out with another pump.No harm or injury to patient reported.

• Brand Name: CARDIOSAVE HYBRID TYPE M PLUG
• 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: 17596048
• Report Number: 2249723-2023-03779
• Device Sequence Number: 17749945
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: 10607567109107
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 02/26/2024

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: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 02/22/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 02/26/2024; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 80 KG