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 Gas Output Problem (1266)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: during preventive maintenance (pm), the getinge field service engineer (fse) found that the unit failed fill manifold portion of all manifold tests.To fix the issue, the fse replaced the helium reservoir assembly (0997-00-0565) and now the unit passes the fill manifold leak test.Unit passes all functional, safety, and electrical tests to factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted when additional information is provided.The initial reporter is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Event Description

It has been reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave unit failed fill manifold leak test.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6 (type of investigations, investigation findings, investigation conclusions), h10, h11 corrected fields: h6 (component codes).

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: 12711073
• MDR Text Key: 278772726
• Report Number: 2249723-2021-02483
• 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: 03/13/2023

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: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1