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

During a preventative maintenance (pm) service, the getinge field service engineer (fse) bent one of the pins on the front end board connection, he ordered the front end board for replacement.He returned to finish the repair/pm and replaced the front end board and completed all diagnostic, performance and safety tests on the unit during pm.The unit was then approved for clinical use and returned to the department.A supplemental report will be submitted upon completion of our investigation.(b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.(b)(6).

Event Description

It was reported that while completing a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the gfe noticed loose connectors on the front end board, so he removed it to tighten the connectors.While reinstalling the front end board he bent one of the pins on the board connection.There was no patient involvement, and no adverse event reported.This report is being submitted for the bent pin.A separate report, 2249723-2021-02482, has been submitted for the loose connectors issue.

Event Description

It was reported that while completing a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fse noticed loose connectors on the front end board, so he removed it to tighten the connectors.While reinstalling the front end board he bent one of the pins on the board connection.There was no patient involvement, and no adverse event reported.This report is being submitted for the bent pin.A separate report, 2249723-2021-02482, has been submitted for the loose connectors issue.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: b5, 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: 12715456
• MDR Text Key: 281411916
• Report Number: 2249723-2021-02498
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 10/21/2022
• 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