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

Model Number 0998-00-0800-83

Device Problems Inability to Auto-Fill (1044); Noise, Audible (3273)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to the customer's site.The stm observed severe damage to rear of console above rear handle.The stm removed console cover and observed pressure hose cut causing massive leak to pressure canister.This damage caused poor augmentation and gas restriction alarms when console covered was installed.The stm replaced console cover, rear latch handle and pressure hose.The stm replaced damaged parts due to customer negligence and corrected failure.The stm then performed all calibration, functional and safety tests on iabp, which passed.The iabp was returned to customer and cleared for clinical use.(b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had an autofill error.Additionally, it was reported that the iabp unit was making noise.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had an autofill error.Additionally, it was reported that the iabp unit was making noise.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was 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: 11382653
• MDR Text Key: 233752220
• Report Number: 2249723-2021-00442
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• Combination Product (y/n): N
• PMA/PMN Number: K0112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1