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 Problem Break (1069)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that the lcd display of the cardiosave intra-aortic balloon pump (iabp) was broken.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.

Manufacturer Narrative

Updated fields; b4, g3, g6, g7, h2, h3, h4, h6, h10, h11.Corrected fields: g1.A getinge technician was not dispatched to evaluate the unit because the customer reported that the unit has not been repaired because of parts delay.Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.The customer provided partial information and stated not to be contacted anymore.Not related to the reported issue, a getinge field service engineer (fse) performed a full scheduled preventive maintenance with all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The pm was completed and the iabp was then released to the customer and cleared for clinical service.

Event Description

N/a.

• 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: 12706728
• MDR Text Key: 281286927
• Report Number: 2249723-2021-02477
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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: Other
• 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
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1