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 Communication or Transmission Problem (2896)

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

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

During the call with the getinge emergency support coordinator, the unit's screen was verified not locked and unit was suggested to be switched out.The console was switched successfully and there was not another alarm since.The affected console was tagged for biomed.A getinge field service engineer (fse) was dispatched and evaluated the iabp, but was unable to reproduce the reported gas loss alarm issue.The fse confirmed multiple "gas loss in iab circuit" alarms in the log file as well as a few "augmentation" alarms preceding the gas loss in iab circuit alarms.It is suspected that the catheter was the cause of the gas loss alarms.There were no electrical faults reported, and the fse reloaded the b.17 software as recommended in three of the faults.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated in is (b)(6).

Event Description

It was reported to the emergency support coordinator that during use on a patient, the screen for the cardiosave intra-aortic balloon pump (iabp) would not respond following a gas loss alarm.The end user followed the help screen but was unable to start the iabp unit as the keys were greyed out.The esc verified that the screen was not locked and suggested switching the console, which was done successfully.No additional alarms were reported to occur.There was no patient harm or injury and no adverse event was reported.This medwatch is for the reported touch screen issue , the gas loss alarm issue has been reported in a separate medwatch.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue.The fse confirmed multiple "gas loss in iab circuit" alarms in the log file as well as a few "augmentation" alarms preceding the gas loss in iab circuit alarms.It is suspected that the catheter was the cause of the gas loss alarms.There were no electrical faults reported, and the fse reloaded the b.17 software as recommended in three of the faults.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

• 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: 14140296
• MDR Text Key: 289495886
• Report Number: 2249723-2022-00887
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 30 KG