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 Audible Prompt/Feedback (2282); Device Contamination with Body Fluid (2317)

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

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) replaced the pneumatic module assembly then completed scheduled preventative maintenance (pm).All safety, functionality, and calibration checks were performed, and all tests passed to factory specifications.The iabp unit was cleared for clinical use, and released to the customer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event with no alarm.It is unknown if there was any patient harm/injury; however there was no adverse event reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event with no alarm.It is unknown if there was any patient harm/injury; however there was no adverse event 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: 10931312
• MDR Text Key: 219342054
• Report Number: 2249723-2020-02047
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• 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
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1