MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported when the unit powered on, the cardiosave intra-aortic balloon pumps(iabp) screen does not turn on and the unit alarms.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during maintenance when the unit powered on, the cardiosave intra-aortic balloon pumps(iabp) screen does not turn on and the unit alarms.

Manufacturer Narrative

Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions, component code), h10, h11.Corrected fields: b5, g2, d5, e1 (initial reporter, event site email ).Additional fields: e1 (event postal code: (b)(6)).It was reported that during preventive maintenance (pm) the cardiosave intra-aortic balloon pump (iabp) screen does not turn on and iabp was leaking.There was no patient involvement.A getinge field service engineer (fse) evaluated and tested the drive manifold for leak.Drive manifold passed all the test.All manifold test observed to have passed and completed all test.For the screen issue fse replaced kit display video generator board.The unit passed all functional and safety tests to factory specifications.The unit was cleared for clinical use.

Event Description

It was reported that during maintenance when the unit powered on, the cardiosave intra-aortic balloon pumps(iabp) screen does not turn on and the unit alarms.There was no patient involvement.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 15311500
• MDR Text Key: 300795261
• Report Number: 2249723-2022-02200
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1