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 Component Incompatible (1108)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device:.The getinge field service engineer (fse) that encountered the issue, replaced with the defective safety disk with another safety disk (sn#(b)(4)).This corrected issue.The pneumatic module was replaced because it contained the only remaining safety disk the fse had on hand, the fse completed the pm.Unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.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 during preventive maintenance (pm) performed by a getinge field service engineer (fse), the membrane leak test portion of the pneumatic interface module leak test failed while replacing the safety disk (oob).There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The national repair center (nrc) received the safety disk, a senior repair technician of the nrc inspected the safety disk per the cardiosave service manual with no visual damage observed.The technician installed the disk into the cardiosave test fixture and tested the safety disk to factory specifications and the cardiosave service manual.The national repair center could not verify the disk failing for the membrane leak test.The disk passed factory specifications.The safety disk passed testing.The safety disk was sent to getinge production department per procedure.The national repair center (nrc) received the safety disk from the getinge production department.Production could not verify the failure of the disk failing the membrane leak test.The safety disk passed testing.Retaining the safety disk in the national repair center per procedure.

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue replaced pneumatic module assembly (0997-00-1178) because it contained the only remaining safety disk the fse had on hand.The fse completed the pm.The unit passed all functional and safety tests according to factory specifications.The iabp was returned to the customer and cleared for clinical use.

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: 12288936
• MDR Text Key: 265425569
• Report Number: 2249723-2021-01748
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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 NOT REQUIRED FOR HARDWARE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 03/13/2023
• Supplement Dates FDA Received: 11/04/2021; 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.