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); Optical Problem (3001)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: event was confirmed as this occurred during a preventive maintenance performed by a getinge fse.The unit was repaired by replacing the fiber optic extension.A supplemental report will be submitted when additional information is provided.(b)(6).

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave unit had a broken fiber optic sensor "connection".There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Corrected field: h10 (repair information).The getinge field service engineer (fse) that encountered the issue reported that the repair of the unit has not been completed and is ongoing.A supplemental report will be submitted if additional information is provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h11.Corrected fields: g1(contact person), h6(problem code & component codes), h10.Fse who encountered the broken fiber optic connector returned and replaced damaged part.Afterwards, during testing fse found the fiber optic connection unable to be plugged in.Fse investigated and found the fo sensor extension connector to be assembled improperly and not allowing the connector to be plugged in.Fse returned with good part, disassembled the unit and replaced with good working part.Fse reassembled unit and performed a full pm functional and calibration check.Unit has passed all test and is now ready 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: 12674139
• MDR Text Key: 277725322
• Report Number: 2249723-2021-02416
• 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,Followup
• Report Date: 07/27/2022

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: 09/28/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 07/27/2022
• Supplement Dates FDA Received: 11/15/2021; 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1