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

Model Number N/A

Device Problems Failure to Zero (1683); Failure to Calibrate (2440)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.(b)(6).

Event Description

It was reported that the cardiosave intra aortic balloon pump (iabp) unit would not zero.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Event Description

It was reported that the cardiosave intra aortic balloon pump (iabp) unit would not zero.It is unknown under which circumstances the event occurred or if a patient was involved; however there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, e1(event site email), e2, e3, g4, g7, h2, h6, h10, h11.Corrected fields: d5, h6(device codes).A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.The fse 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 the cardiosave intra aortic balloon pump (iabp) unit would not zero.It is unknown under which circumstances the event occurred or if a patient was involved; 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: 10780261
• MDR Text Key: 219372132
• Report Number: 2249723-2020-01814
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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: Other
• 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: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 01/08/2021
• Supplement Dates FDA Received: 12/05/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1