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 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) has a possible circuit board issue.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4,d9,e1(site country),g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions), h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) unit has a possible circuit board issue.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.A getinge field service engineer (fse) stated that this is duplicate so.Refer to so#44018144 for repair and sign off.Replaced video generator board as per service manual and ensured software compatibility.Unit ran without issue for 30mins.Calibration, safety, and functionality checks passed factory specifcations.Returned to customer upon completion.

• 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: 14314475
• MDR Text Key: 291296345
• Report Number: 2249723-2022-01062
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: Other
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1