MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-83

Device Problem Mechanical Problem (1384)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) unit cover for fiber optic connection won't stay over the open connection port.There was no patient or staff injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) evaluated unit.Fiber optic cover loose.Fse tightened screw on the back of the cover.Machine has been taken out of service to perform coiled cable field action.Attempts have been performed to obtain additional information.No response has been provided.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

Event Description

N/a.

• Brand Name: CARDIOSAVE RESCUE
• 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: 17568276
• MDR Text Key: 322071165
• Report Number: 2249723-2023-03749
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.