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

Device Problems Device Sensing Problem (2917); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arrhythmia (1721); Failure of Implant (1924)

Event Date 09/14/2022

Event Type  Injury  

Event Description

It was reported that during use the intra-aortic balloon pump (iabp) suddenly showed alarm of optic sensor failure.Instructions to trouble shoot the device were followed, but the alarm continued.The customer spoke with device representative but the issue was not resolved.Throughout the rest of the shift, every pvc/pac beat the patient had on the bedside monitor, the unit was unable to receive an appropriate trigger and the device would automatically default into "standby" mode, thus not supporting the patient.The patient was experiencing more ectopy thereafter and the unit had to be manually restarted every few seconds.During this time, the patient denied any pain/discomfort.The patient was taken to the cath lab for replacement of the iabp catheter and the console was also changed out.Medwatch # mw5112091.

Manufacturer Narrative

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

Manufacturer Narrative

It was later informed by the customer that the unit was placed back into service after evaluation and maintenance which was performed by the customer.The customer also stated that the issue was more about the optical sensor of the catheter rather than the console, even though the console was changed out.No other information was provided regarding the repair.This complaint will be closed, if further information is received in regards to the repair of the unit, the complaint will be opened and updated accordingly.

• 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: 15615690
• MDR Text Key: 301840202
• Report Number: 2249723-2022-02679
• Device Sequence Number: 1
• Product Code: DSP
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 94 KG