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

Model Number N/A

Device Problem Failure to Zero (1683)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to zero the pressure without issue.The fse tested the calibrations of the touch screen and display and all testing passed.Subsequently, the fse completed 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 in has been abbreviated; the full name should read (b)(6).

Event Description

It was reported that during testing performed by the customer's biomedical engineer, the cardiosave intra-aortic balloon pump (iabp) was unable to zero the pressure.There was no patient involved and no adverse event was reported.

Event Description

It was reported that during testing performed by the customer's biomedical engineer, the cardiosave intra-aortic balloon pump (iabp) was unable to zero the pressure.There was no patient involved and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F 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: 11040483
• MDR Text Key: 222761970
• Report Number: 2249723-2020-02179
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1