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 10/24/2023

Event Type  malfunction  

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit had an internal communication failure reported during boot up.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: (type of investigation, investigation findings, component codes, investigation conclusions).Corrected fields: (health effect ¿ impact codes).A getinge field service engineer (fse) evaluated the cardiosave pump.Fst was able to again power up device without issue.The following errors logged again multiple times in the event logs: fault code # 107 - "an isolation digital signal processor (dsp) reported excessive voltage data on the front end board".Fault code # 67 - "a failure communicating the correct voltage to the hydraulic blood pressure sensor".Power management board was replaced.Iabp was cycled on/off several times without issue.Iabp was exercised on test catheter and patient simulator without failure.Device passed all calibration, functional testing and electrical safety checks to factory specifications.The following investigation was performed by technician of the maquet failure analysis and testing dept.(fat) (b)(6).The failure analysis and testing dept.Received part, with a reported unit failure of a fault 107 and fault 67 power up codes.The fat performed a visual inspection and found the part to be in good condition.The fat installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.Tested the board for 1 hour with no issues or fault codes arising.Fat was not able to verify the reported failure.This revision is obsolete and no longer able to be tested by a supplier.

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit had an internal communication failure reported during boot up.There was no patient harm.

• 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: 18057656
• MDR Text Key: 327194399
• Report Number: 2249723-2023-04703
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1