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

Model Number 0998-00-0800-53

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be upon completion of our investigation.

Event Description

It was reported that during the 8 year preventive maintenance (pm) performed by a getinge service territory manager (stm), the unit would not boot.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, e1(site country), g3, g6, g7, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10, h11.Corrected fields: d5, e1(initial reporter, event site email), g2.A getinge field service engineer (fse) found 2 bend male connector pins on the front end pcb and replaced front end board.The bent connector pins was caused by fse during reassembly do to a misalignment when re seating the front end pcb.Rebooted b.17 software and calibrated.Functional tested without any further failures or issues.Cardiosave iabp pm services completed.Full pm, safety, calibration, and functionality checks to factory specifications.Released to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing department inspected a front end board, and notice that the j11 pins were bent and can't make contact with the main board.No further test can be done due to the pins being bent.Retaining the front end board in the failure analysis and testing department per procedure.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to define.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: 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: 16302804
• MDR Text Key: 308839152
• Report Number: 2249723-2023-00960
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1