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

Model Number 0998-00-0800-65

Device Problem Power Problem (3010)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during in-house inspection, the cardiosave intra-aortic balloon pump (iabp) unit generated an alarm from the power management board.There was no damage.

Manufacturer Narrative

Updated data: b4,d5,e1(event site name),e2,e3,e4,g3,g6,h2,h6(clinical&impact).Corrected data: h10(comment entered in f/u #1 is to be removed this complaint is reportable).

Event Description

It was reported that during in-house inspection by getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit generated an alarm from the power management board.There was no patient involvement.

Manufacturer Narrative

This record is being closed as it was opened in error.

Event Description

This record is being closed as it was opened in error.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the alarm was generated from the power management board.The power management board (d670-00-1162) was replaced and unit passed all functional and safety tests.The unit was returned to customer in good working condition.

Event Description

N/a.

• 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: 18134850
• MDR Text Key: 328132718
• Report Number: 2249723-2023-04865
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.