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

Model Number N/A

Device Problem Failure to Sense (1559)

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

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

In october 28, 2020 we received an email from customer ((b)(6) and it was confirmed that the iabp did have a fiber optic repair on the cardiosave with s/n # (b)(4).In addition we were informed that the service was completed on (b)(6) 2020.The reported problem could not be reproduced by the biomed.If additional information is received, we will reopen and update the complaint.Not returned to manufacturer.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fiber-optic issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fiber-optic issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6 (type of investigation), h10.Correction fields: b3, d9.

• 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: 10874991
• MDR Text Key: 217372173
• Report Number: 2249723-2020-01967
• 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: 04/23/2021

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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1