MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per sop (b)(4) since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to evaluate this unit. The fse tried to switch the machine on but he got the same reported failures. There was no power-up failure codes on the monitor because of booting not completed. But on the other hand, the system diagnostics mode has booted normally. The fse was trying to switch on/off the machine a few times more but machine was not able to started operate in operate mode. The fse took the console out from the cart, took the cover from console out and saw on the executive processor board led readouts ¿f0 ¿. He tried off/on thy system again and it was successful. The system booted correctly up with the power-up failures: power-up test fails code #10, the transducers not calibrated and no backup battery detected. As per the manual, the fse performed the 30 psi transducers and the calibration, but the problem was not fixed. The fse performed 30 psi transducers and calibration again. Transducer gain checks were done according to the service manual and all passed. The fse also found the date, time and user language have been set incorrectly, and he fixed the issue and set up the correct values. After off/on the cardiosave system the black touch screen has appeared again with the continuous tone. All manifold test was done with a pass result. Front end board, executive processor board and back plane were not damaged by saline. The other device was used instead.

Event Description

It was reported that prior to use on a patient the cardiosave intra-aortic balloon pump (iabp) was not able to boot up in operate mode. The iabp presented the maquet logo on the (top) monitor and black touch screen with blue rotating circle on it and continuous tone was hearable. There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Updated fields: corrected fields: (results & conclusion code) address: (b)(4) phone: (b)(4). A getinge fse replaced the executive processor board. The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that prior to use on a patient the cardiosave intra-aortic balloon pump (iabp) was not able to boot up in operate mode. The iabp presented the maquet logo on the (top) monitor and black touch screen with blue rotating circle on it and continuous tone was hearable. There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7841489
• MDR Text Key: 119329845
• Report Number: 2249723-2018-01518
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse