MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE BATTERY CHARGING STATION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0802
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
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 was overheating on a patient.
Additional Manufacturer Narrative
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.A supplemental report will be submitted if additional information is provided.Device not returned to manufacturer.

• Brand Name: CARDIOSAVE BATTERY CHARGING STATION
• 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: 17825060
• Report Number: 2249723-2023-04238
• Device Sequence Number: 2343197
• Product Code: DSP
• UDI-Device Identifier: 10607567111964
• UDI-Public: 10607567111964
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 0998-00-0802
• Device Catalogue Number: 0998-00-0802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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