MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-83

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.Not returned to manufacturer.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was leaking.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) was leaking.It is unknown under which circumstances this event occurred, however there was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Corrected fields: d4 (catalog#).A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The fse was unable to confirm the issue.The iabp operated normally upon arrival.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.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was leaking.It is unknown under which circumstances this event occurred, however there was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE RESCUE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11101493
• MDR Text Key: 226044894
• Report Number: 2249723-2020-02264
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• 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,Followup
• Report Date: 04/19/2021

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 Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/09/2021; 04/19/2021
• Supplement Dates FDA Received: 02/25/2021; 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1