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); Incomplete or Inadequate Connection (4037)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named is a getinge employee whose full name has been shortened due to field character limit and is (b)(6).A contact at the event site is: (b)(6).Testing of actual/suspected device: to fix the issue discovered the getinge field service engineer (fse) replaced the front-end pcb assembly was replaced, the b.17 software reloaded and 30psi transducers were recalibrated.The fse completed preventive maintenance was performed with full calibration, functional testing and electrical safety checks to meet manufacturer specifications.The unit was returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service tech, the unit had a damaged blood pressure (bp) connector, and bp cable malfunction.There was no patient involvement nor adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue determined that the connector on the board was defective as multiple blood pressure cables and patient simulators failed to connect.

• 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: 14408906
• MDR Text Key: 291740452
• Report Number: 2249723-2022-01143
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• 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
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1