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

Model Number 0998-00-0800-45

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that prior to use it was observed by the customer that the cardiosave intra-aortic balloon pump (iabp) had a beeping sound when the battery was inserted in slot 1.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) evaluated the iabp unit, and found that the buzzer sound was coming from the iabp unit and not the battery.When verifying the logs there was an alarm code #118 observed.The fse replaced the power management board which corrected the issue and 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.It is expected that the suspected faulty power management board will be returned to getinge's national repair center for failure analysis; a supplemental report will be submitted upon completion of failure analysis.Event site address was shortened due to field character limit and should read: (b)(6).

Event Description

It was reported that prior to use it was observed by the customer that the cardiosave intra-aortic balloon pump (iabp) had a beeping sound when the battery was inserted in slot 1.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit, and found that the buzzer sound was coming from the iabp unit and not the battery.When verifying the logs there was an alarm code #118 observed.The fse replaced the power management board which corrected the issue and 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.It is expected that the suspected faulty power management board will be returned to getinge's national repair center for failure analysis; a supplemental report will be submitted upon completion of failure analysis.Event site address was shortened due to field character limit and should read: (b)(6).

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13544870
• MDR Text Key: 286082718
• Report Number: 2249723-2022-00299
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1