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 Break (1069); No Device Output (1435)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) unit recorder not printing properly, broken display cover and bezel.There was no patient involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional info: contact person ( (b)(6) ).It was reported that the cardiosave intra- aortic balloon pump (iabp) had recorder (printer) related malfunction.There was no patient involvement or adverse event reported.A getinge fse was dispatched to evaluate the unit.Fse found that the printer was not clearly printing the strip d161-00-0024-04 printer,thermal,xe-50b, was replaced.Also found that the display top and bezel were badly damaged, also replaced them along with the associated parts.When removing the bezel, the display screen shattered so replaced.Then completed the rest of the pm testing with no other issues.The unit was approved for clinical use and returned to the department.The failure analysis and testing dept.Received the following parts associated with this complaint: part - would not print consistently.Part damage on the corner of the screen, please see attachment.The fat installed part in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.Failed the printer test as it would not print consistently.Fat was able to verify the reported issue for both of these parts.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Ap.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

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: 17899158
• MDR Text Key: 325717378
• Report Number: 2249723-2023-04366
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.