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	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during installation the cardiosave intra-aortic balloon pump (iabp) unit failed to recognize the new battery.The battery was swapped between bays and the error moved with the battery.A battery from an already installed cardiosave was inserted into the new unit to observe if the issue was the battery or the new unit.The error remained on bay 1 regardless of the batteries inserted.There was no patient involvement.
Additional Manufacturer Narrative
The getinge field service engineer (fse) that observed the issue installed new cardiosave battery (0146-00-0097) into a cardiosave.The cardiosave failed to recognize the battery.Swapped the battery between the bays and error moved with the battery.Installed the old battery again, with no faults appearing.If additional information is received, we will reopen and update the complaint.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

• 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: 16264567
• Report Number: 2249723-2023-00710
• Device Sequence Number: 4337684
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown