MAUDE Adverse Event Report: DATASCOPE CORP. POWER SUPPLY, REMOVABLE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0014-00-0085
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
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 by the customer that during transport, one of the securing pins on the cardiosave intra-aortic balloon pump (iabp) ac power supply broke.There was no patient injury or death associated with this incident.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4 (udi, catalog, version, serial), h6 (type of investigation, investigation findings, investigation conclusion).Additional information was requested from the fse with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.H3 other text: device evaluated/ repair status unknown.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.

• Brand Name: POWER SUPPLY, REMOVABLE
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19101055
• Report Number: 2249723-2024-01535
• Device Sequence Number: 7428447
• Product Code: DSP
• UDI-Device Identifier: 10607567111995
• UDI-Public: (01)10607567111995(21)160019305SLPE
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: 0014-00-0085
• Device Catalogue Number: 0014-00-0085
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 07/04/2024; 01/31/2025
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/15/2024; 02/03/2025
• 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