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

Model Number N/A

Device Problems Pumping Stopped (1503); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the aware date.A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The customer's biomed ran the iabp overnight on a test balloon at 120 bpm and the iabp displayed no over-temp messages.The fse then performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed high temperature error (system over temperature message) on the screen and stopped pumping.The iabp was replaced with another iabp and therapy continued.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed high temperature error (system over temperature message) on the screen and stopped pumping.The iabp was replaced with another iabp and therapy continued.There was no harm or injury to the patient 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
• MDR Report Key: 10203240
• MDR Text Key: 196750609
• Report Number: 2249723-2020-00989
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1