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

Model Number N/A

Device Problems Contamination (1120); Output below Specifications (3004); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge stm performing pm noted that upon review of the iabp log files, nothing unusual was identified except a normal fault code #77.To correct the issue, the stm replaced the scroll compressor, pressure muffler, and vacuum muffler.Upon further investigation, the stm identified saline inside the backplane to coiled cord cable, and on the pneumatic interface board and replaced the parts.Subsequently, the stm completed pm service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The first name of the initial reporter has been abbreviated due to field character limit; the full name should read (b)(6).The initial reporter named is a getinge employee whose contact details are: telephone number (b)(6), email address (b)(6); which differs from that of the event site.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the compressor of the cardiosave intra-aortic balloon pump (iabp) failed to raise the pressure to meet factory specifications and was rising very slowly and was still not meeting specifications in about 22 seconds.There was no patient involved 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: 8723731
• MDR Text Key: 149077500
• Report Number: 2249723-2019-00995
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• 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
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1