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 Failure to Charge (1085)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to verified the reported issue.The fse troubleshoot and found the problem to be the power management board.The problem was not corrected yet and since there is no service order report available, a supplemental report will be submitted when this information is provided to us.

Event Description

It was reported that during charging and checking the battery in the cardiosave intra-aortic balloon pump (iabp) will not charge.The unit charging led indicator intermittently turns on and off every 20 or 30 seconds.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, b6, b7, d10, e1(event site email), g2, g3, g6, g7, h2, h6(investigation type & investigation conclusions), h10, h11.Corrected fields: b3, d1, d4(model#), d5, g1(contact person), h4 *the aware date reported in the initial report was submitted incorrectly.The aware date should read: 03/31/2021.Good faith efforts (gfes) have been made in attempt to obtain more information.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

Event Description

N/a.

• 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: 11736840
• MDR Text Key: 247689296
• Report Number: 2249723-2021-00879
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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: 04/05/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose