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

Catalog Number 0998-00-0800-31

Device Problems Failure to Power Up (1476); Failure of Device to Self-Test (2937)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted.A getinge service engineer evaluated the iabp.He reported that he checked all the connections as well as running full testing and calibrations.The service engineer stated that he was unable to replicate the alleged malfunction and the iabp was working within specification.

Event Description

It was reported that when the cardiosave intra-aortic balloon pump (iabp) was turned on, it would not start and it stated that its self-test had failed.It generated power up test fails code #14.There was no patient involvement or adverse event 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: 7704985
• MDR Text Key: 114729482
• Report Number: 2249723-2018-01222
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/17/2018

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: Other
• Device Catalogue Number: 0998-00-0800-31
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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