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

Model Number 0998-00-0800-53

Device Problems Pumping Stopped (1503); Unexpected Shutdown (4019)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) was shutting off randomly without any warning.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) evaluated the iabp unit, but was unable to reproduce the reported issue.The logs showed no signs of power failure, the system checkout was completed, however the systems safety disk expired due to inflations and the pump was taken out of service until parts are available for install.Another getinge fse arrived at the customer's site at a later date to perform preventative maintenance (pm).The fse replaced the expired 9v battery, both battery packs, and the tidal volume disk.All parts replaced were in relation to pm service and not the reported issue.Subsequently, the fse completed pm service including 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.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11 corrected fields: g1(contact person).

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12699383
• MDR Text Key: 282045902
• Report Number: 2249723-2021-02467
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 48 KG