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 Problems Smoking (1585); Failure to Calibrate (2440); Unexpected Shutdown (4019)

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

Event Date 09/04/2021

Event Type  malfunction  

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) on (b)(6), 2021, i was notified by the director that the machine was suddenly shut down during use, and white smoke was coming out from the lower end of the machine.Arrived at the scene on september 13, and the battery could not be turned on.After connecting the ac power, the device turned on directly, and an alarm buzzer sounded.Preliminary suspicion of power management board failure.On (b)(6), the power management board was replaced.The power management board was burned and there was white smoke.The fault still exists.It is suspected that the frame power module is faulty.On (b)(6), 2022, the frame power module and power management board were replaced, and the device could be turned on and off normally, but the power-on alarm displayed "#6 electrical test failed" and could not be calibrated.On (b)(6), the calibration was successful in the hospital again, but the simulation balloon failed to inflate, and the test suspected that the pneumatic module was faulty.On (b)(6), it was replaced with a new pneumatic module, and the fault still exists.The pressure gauge was used for on-site calibration, but it could not be calibrated.Considering that the device has other faults, it is necessary to further judge the fault.It is unknown if there was any patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields; b4, d9, g3, g6, h2, h3, h4, h6, h10, h11.Corrected fields; h6 (medical device problem code).A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit because the distributor arrived at the scene, the battery could not be turned on, and the device was turned on directly after the ac power was connected, and there was an alarm beep.It is initially suspected that the power management board is faulty, so the power management board was replaced.The power management board was burned and there was white smoke when the power was turned on.The fault still existed.It was suspected that the power module of the frame was faulty, so the frame power module and power management board were replaced.The equipment can be turned on and off normally, but the alarm shows "#6 electrical test failed" and cannot be calibrated.The calibration was successful again at the hospital, but the inflation of the simulated balloon test failed, and the test suspected that the pneumatic module was faulty so it was replaced with a new pneumatic module, but the fault still existed.The pressure gauge was used to calibrate on-site, but it could not be calibrated.Considering that the device has other faults, it is necessary to further judge the fault.The drive manifold (0104-00-0031) was replaced to resolve the issue.The unit passed all functional testing after repair and was returned to the customer.

Event Description

N/a.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) suddenly shut down, white smoke was coming out from the lower end of the machine, and it alarmed.The iabp was swapped out to continue therapy.There was no patient injury.

Manufacturer Narrative

Updated fields:b4, e1(site country), e2, e3, g3, g6, h2, h6(component codes), h10, h11.Corrected fields.

Event Description

N/a.

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15026946
• MDR Text Key: 304713026
• Report Number: 2249723-2022-01711
• 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: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.