MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH ASSY,SAFETY DISK,ENGLISH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0997-00-0985-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intra-aortic balloon pump (iabp) accessory, ekg cable isn't working, needs new cable.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that before use, the intra-aortic balloon pump (iabp) accessory, ekg cable isn't working, needs new cable.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9, e1 (site country, event site mail), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11.Corrected fields: e3.Additional customer contact phone: (b)(6).At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer 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.
Event or Problem Description
N/a.

• Brand Name: ASSY,SAFETY DISK,ENGLISH
• 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: 15924256
• Report Number: 2249723-2022-03124
• Device Sequence Number: 6689760
• Product Code: DSP
• UDI-Device Identifier: 10607567107417
• UDI-Public: 10607567107417
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/12/2024

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: 0997-00-0985-01
• Device Catalogue Number: 0997-00-0985-01
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 03/08/2024
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/30/2023; 03/12/2024
• 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