MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-83

Device Problem Failure to Charge (1085)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

Additional info: contact person(name: (b)(6).It was reported that cardiosave intra-aortic balloon pump (iabp) not charging the battery properly.A getinge field service engineer (fse) evaluated found that battery would not charge properly.The unit had an expired battery installed at the time of testing.Unit is a transport unit only one battery installed and a power supply installed in battery bay #2.There were no errors in the error log.Examined the power management board.No electrical or physical damage seen.Replaced the battery pack position #1 during the pm procedure and power management board (d670-00-1162).Verified that the that the console would charge the batteries to full capacity.No patient involvement.

Event Description

N/a.

• Brand Name: CARDIOSAVE RESCUE
• 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: 18317232
• MDR Text Key: 330335289
• Report Number: 2249723-2023-05284
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• 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: 05/15/2024

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: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1