MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number 0998-00-0800-53

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a fiber optic that was reading "sensor failure." no patient was involved.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

The full name of the initial reporter in block e1 was shortened due to field character limit; the full name is (b)(6).A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse inspected the unit and found that the plastic guide for the fiber optic connector was broken and not allowing the connection to seat properly.The fse ordered a new fiber optic cable assembly and returned to the customer site to perform the replacement.Once the assembly was replaced, the fse completed all diagnostic, performance and safety tests with no further issues.The unit was approved for clinical use and returned to the user.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• 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: 14848863
• MDR Text Key: 302054529
• Report Number: 2249723-2022-01492
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/21/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1