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 Premature Discharge of Battery (1057)

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

Event Date 06/07/2023

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) units 9v critical alarm battery failed prematurely.There was no patient involvement.

Manufacturer Narrative

Additional point of contact: name: (b)(6).Phone number: (b)(6).Email id: (b)(6).Contact department: clinical engineering.Contact person occupation: biomedical engineering.A getinge field service engineer (fse) during a preventative maintenance (pm) service repair found that the 9v critical alarm battery had failed prematurely.  the battery showed signs of corrosion around the seams of the battery.To fix this issue fse replaced the battery and completed a full pm.All tests passed to factory specifications.Unit returned to the customer and released for clinical use.

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: 17148186
• MDR Text Key: 317783987
• Report Number: 2249723-2023-02837
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1