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 Problems Circuit Failure (1089); Device Displays Incorrect Message (2591)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) part#: 0670-00-0770 after replacing executive processor board installing the board re-load software b.17.Power cycle the machine to user mode gave an error "power-up test fails code#: 10".Double check the board the led has a code#: f5 "failed to load software image out onboard flash.New executive processor board out of the box failure.There was no patient involvement.

Manufacturer Narrative

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

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

It was reported that the cardiosave intra-aortic balloon pump (iabp) power-up test fails code #10¿ even after power cycling machine several times.Getinge field service engineer (fse) after replacing executive processor board installing the board re-load software b.17.Power cycle the machine to user mode gave an error "power-up test fails code #10".Double check the board the led has a code #f5 "failed to load software image out on board flash.The equipment works to the manufacturer¿s specs,.The patient involvement is unknown.The equipment was cleared for customer use.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.The failure analysis and testing department received the following parts associated with this complaint: executive processor board.This part was received with a reported unit failure message of power up tests fail code#10.Performed visual inspection of this part received and part looks to be in good condition.Installed the executive processor board into the cardiosave test fixture sn (b)(6) and tested to the factory specifications per pn 0002-07-d016 revision d and the cardiosave service manual pn 0070-00-0639 revision q.The failure analysis and testing department verified the failure of power up test fails code# 10.The executive processor board failed testing.Retaining the board in the fat dept.As per procedure (b)(4) rev ak.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Manufacturer Narrative

The fat dept.Received part number exec.Processor board from the supplier.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.Supplier investigation: skip ict and hi-pot testing process (since the date codes of t1 and t3 are less than 1502).Only fct and manual tests are performed, and both have passed.Retaining this board in the fat dept.Per procedure 0002-07-d008 rev aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

• 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: 16245843
• MDR Text Key: 309190738
• Report Number: 2249723-2023-00479
• 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,Followup
• Report Date: 03/18/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 03/07/2023; 03/14/2024
• Supplement Dates FDA Received: 03/22/2023; 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose