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

Model Number 0998-00-0800-52

Device Problems Misconnection (1399); Appropriate Term/Code Not Available (3191)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that during a routine check, the battery in the cardiosave intra-aortic balloon pump (iabp), got stuck in the charging station, when it was unlocked.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge service engineer was dispatched to evaluate this unit and found the battery was not coming out once it was unlocked.The service engineer enlarged the connection point of the battery to make the connection between the battery and machine loosen a bit.After adjustment, the battery was able to eject out every time when it was unlocked.The service engineer reported that the battery was functioning.In addition, the charging function was checked and it was normal.The machine was then returned to customer for clinical use.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields; b4, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields: d5, g1, h6 (medical device ¿ problem code).

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID INT 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: 13102328
• MDR Text Key: 287138981
• Report Number: 2249723-2021-02984
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1