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

Model Number 0998-00-0800-52

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse tried the mains on another unit, the mains worked fine.The fse replaced the power supply in the cart.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was not working on mains.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 during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was plugged in and the customer noticed no charging led.There was no patient involvement.

Manufacturer Narrative

In the previous follow up, operator was selected as healthcare professional, but it is 'others'.

• Brand Name: CARDIOSAVE HYBRID, TYPE G PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14046300
• MDR Text Key: 289773349
• Report Number: 2249723-2022-00771
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2024

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: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 07/23/2022; 02/02/2024
• Supplement Dates FDA Received: 07/10/2023; 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1