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

Model Number 0998-00-0800-52

Device Problem No Display/Image (1183)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) screen goes off.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10, h11 corrected fields: d5, e2, e3, g2 additional information: event site postal code: (b)(6).A getinge field service engineer (fse) on (b)(6) 2024 went onsite and found that the unit could not enter the service mode.He will provide a temporary quotation for the acknowledgement so as to proceed with the repair in advance.(b)(6) 2024 troubleshoot the problem and found that the screen issue is resolved.However, the pcba video generator will be put on hold and unit for monitoring.Temperature sensor replaced and performed all manifold and compressor output tests.Unit ok.Will perform overheat test on (b)(6) 2024 as agreed with bme for 3 days before closing this case.(b)(6) 2024 replaced the screen with a loaner from getinge.The machine was run from (b)(6) 2024 to (b)(6) 2024 and no issue was found.The service mode was also randomly tested at different intervals for 10 times and no issue found.Final quotation amended and issued.Will recommend to replace those parts stated.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 18542468
• MDR Text Key: 333231375
• Report Number: 2249723-2024-00225
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1