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

Model Number N/A

Device Problems Leak/Splash (1354); Connection Problem (2900); Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2019

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to evaluate this unit and was unable to reproduce the reported issue.However; the fse was able to verify the alarm in the error logs.The fse performed leak tests along with all functional and safety tests as per factory specifications.The unit passed all tests performed and was returned to customer and cleared for clinical use.

Event Description

It was reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated an iab disconnect alarm; in addition, the unit emitted a loud leaking sound.There was no patient harm and no adverse event was reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) generated an iab disconnect alarm; in addition, the unit emitted a loud leaking sound.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
• MDR Report Key: 8443359
• MDR Text Key: 139717929
• Report Number: 2249723-2019-00446
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1