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

Model Number 0998-00-0800-65

Device Problem Communication or Transmission Problem (2896)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/20/2023

Event Type  Death  

Manufacturer Narrative

Due to character restrictions in block e1 event site name : (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit had an internal communication error.Approximately 1.5 to 2 hours after the start of use, an internal communication error occurs with an alarm sound.Since there was no iabp to replace immediately, the iab catheter was removed and iabp use was discontinued.The iabp unit was once turned off and on again.When this iabp unit was booted up, the normal operating mode was not displayed and the system diagnostics mode was displayed instead.Iabp therapy was unable to be continued with this iabp unit.Furthermore, no replacement unit was available at this facility.Therefore the iabp therapy for this patient was discontinued by a physician's discretion.On (b)(6) 2023, in the morning, the additional information was obtained from a medical engineer at this facility.The patient was reported to be in an unstable condition.On (b)(6) 2023, at noon, our fse and sales rep.Met with a physician.According to the physician, the patient has expired.According to the physician, the patient presented to emergency room due to cardiopulmonary arrest (cpa).This iabp unit was checked at the service center after returning from the facility.This iabp unit was booted-up normally when it was turned on.An error code #106 has been recorded in the fault logs of this iabp unit.It was noted that this iabp unit shut down unexpectedly during use on the patient on (b)(6) 2023, which was reported in tw805854/(b)(4).Reportedly, error codes #111 and #112 have been recorded in the fault logs of this iabp unit.Therefore executive processor board was replaced.

Event Description

N/a.

Manufacturer Narrative

This iabp unit was checked at the service center after returning from the facility.This iabp unit was booted-up normally when it was turned on.An error code #106 has been recorded in the fault logs of this iabp unit.On 21 august 2023, this iabp unit was turned on and booted up normally.On 22 august 2023, running test was performed for 9 hours and a half.Neither alarms nor errors appeared during the running test.On 25 august 2023, at 14:00, running test was performed again.At 16:04 on the same day, this iabp unit was emitting an alarm and ¿system failure¿ and ¿low vacuum¿ error messages were displayed.The display of the error message was changed to ¿internal communication error¿.Later on, three attempts to boot up of this iabp unit were made, the internal communication error was displayed on the monitor with an audible alarm.The error code #106 has been recorded in the fault logs.Additional information has been requested regarding the repairs, and if provided a supplemental report will be submitted.

• 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: 17666405
• MDR Text Key: 322449199
• Report Number: 2249723-2023-03870
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death