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

Model Number N/A

Device Problems No Device Output (1435); Failure to Power Up (1476); Charging Problem (2892); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. The getinge field service engineer (fse) that discovered the issue replaced the power slot interface board; however this did not resolve the issue. The fse examined the iabp and found saline was spilled inside the iabp; the fse indicated that the spill might have caused component damage to the power management board, the fse order and replaced it. The fse reported that the iabp was experiencing power failure during compressor startup; to fix this issue the fse replaced the compressor, drive manifold, motor control board without solving the issue. The fse then replaced the backplane and this improved the condition of the iabp. However, the compressor would not turn on, to address this latest issue the fse replaced the motor control board. The fse then performed 30psi calibration and passed; the fse indicated that the printer was not working on the iabp, to fix this issue the fse replaced the printer interface. A full pm was performed and all functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service. A supplemental report will be submitted upon failure investigation completion by getinge's national repair center. (b)(6).

Event Description

It was reported that during the inspection of a demo cardiosave intra-aortic balloon pump (iabp) by a getinge field service engineer (fse) that the printer was not working and the battery slot two was not charging. Additionally, saline was found in the iabp and it was also experiencing power failure during compressor startup. There was no patient involvement and no adverse event was reported.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8580156
• MDR Text Key: 144163519
• Report Number: 2249723-2019-00722
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/03/2019
• 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: 0998-00-0800-53
• 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: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse