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

Model Number 0998-00-0800-52

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a continuous alarm and showed an error code that was along the lines of power code failure.The help menu   prompted the user to turn the iabp off for 10 seconds before powering it back on and   that if the problem persists, the iabp should be swapped and taken out   of service.This was attempted and the same thing happened; loud   continuous alarm with the same "power failure" error message.The customer noted: the batteries were fully charged and the iabp was plugged into the   wall with charging confirmed on the screen.Iabp was swapped and they had no issues with the replacement.Later, the iabp would not power up to the main screen at all.Upon starting up, the continuous alarm sounded but the screens froze on the blue maquet loading screen.

Manufacturer Narrative

Corrected data: b5, b6, b7, d10, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a continuous alarm and showed an error code that was along the lines of power code failure.The help menu   prompted the user to turn the iabp off for 10 seconds before powering it back on and   that if the problem persists, the iabp should be swapped and taken out   of service.This was attempted and the same thing happened; loud   continuous alarm with the same "power failure" error message.The customer noted: the batteries were fully charged and the iabp was plugged into the   wall with charging confirmed on the screen.Iabp was swapped and they had no issues with the replacement.Later, the iabp would not power up to the main screen at all.Upon starting up, the continuous alarm sounded but the screens froze on the blue maquet loading screen.There was no patient involvement.

Manufacturer Narrative

Updated fields - b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) had power up fail code.Customer states that upon starting up the iabp, the continuous (and rather ear-splitting) alarm sounded and the iabp showed an error code that was along the lines of "power code failure".Customer jumped into the ¿help¿ menu, and it prompted them to turn the iabp off for 10 seconds before powering it back on and that if the problem persists, the iabp should be swapped and taken out of service.I tried this and the exact same thing happened; loud continuous alarm with the same "power failure" error message.The batteries were fully charged and the iabp was plugged into the wall with charging confirmed on the screen, if that helps.Customer swapped the iabp and had no issues with the replacement.However, customer inspected the defective iabp later and it won¿t power up to the main screen at all.Upon starting up, the continuous alarm sounds but the screens freeze on the blue macquet loading screen.Despite gfes (good faith efforts), no response has been received regarding any repair or the status of the iabp.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.H3 other text : repair not completed.

• Brand Name: CARDIOSAVE HYBRID, 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.; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18915495
• MDR Text Key: 337803649
• Report Number: 2249723-2024-01119
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2024

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: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/15/2024; 07/04/2024
• Supplement Dates FDA Received: 03/22/2024; 07/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1