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 Failure to Charge (1085)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , that the cardiosave intra-aortic balloon pump (iabp) battery bays were not charging either battery.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields - b4,d9,g3,g6,h2,h3,h4,h6(type of investigation,investigation findings,component code,investigation conclusions,h10,h11.Corrected fields - e1(initial reporter,event site email),e2,e3.A getinge field service engineer (fse) had evaluated the unit and it was being found that neither battery bays charging either battery.Than the problem had been troubleshooted further from which the fse had replaced the pcba, cardiosave rohs, power management board from which both the battery bays are being charging.After the replacement the product had passed all the functional and safety tests per factory specifications.The defective components were received for further investigation.The failure analysis and testing dept.Received part number 0670-00-1162 rev.B, serial number: (b)(6) swemco with a reported unit failure of the batteries not charging.The fat performed a visual inspection and found the part to have a damaged q27 component.Fat will not install and test this part due to the risk to the test fixture.Fat verified that the board was faulty.This revision is obsolete and not able to be tested by the supplier.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

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: 18546115
• MDR Text Key: 333277679
• Report Number: 2249723-2024-00280
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1