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 Loose or Intermittent Connection (1371)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) the cardiosave intra-aortic balloon pump (iabp) ecg and pressure connector ports were loose.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

Fse removed the front end board to tighten the nut on both the ecg and pressure connector ports.When reinserting the frond end board, one of the connection pins was not aligned properly and folded over.When fse tried to straighten it out, it broke off.The fse ordered the front end board and returned to the facility to replaced it.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation the initial reporter named is a getinge employee whose contact details differ from that of the event site.A contact at the event site is: (b)(6).The full name of the event site in was shortened due to field character limit; the full name is (b)(6).

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10, h11.Corrected fields: g1(contact person).

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: 12707942
• MDR Text Key: 281846817
• Report Number: 2249723-2021-02482
• 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: 09/22/2022

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
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 09/28/2022
• 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