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

Device Problem Device Emits Odor (1425)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) smelled when tank was opened.

Manufacturer Narrative

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

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) smelled when tank was opened.There was no patient harm.

Manufacturer Narrative

Corrected data: b5, h6 (clinical & impact code).Updated data: b4, g3, g6, h2, h10, h11.

Manufacturer Narrative

Corrected fields: e3, h6 (health effect ¿ clinical code) it was reported that the cs300 intra-aortic balloon pump (iabp) had odor related malfunction.The patient involvement is unknown but no harm reported.Customer reports smell from tank.Getinge field service engineer (fse) arrived onsite and was not able to verify smell from helium tank however there was a odor coming from the battery compartment of the unit.Replaced batteries due to swollen hot batteries.Completed repair, calibration, full functional tests and safety tests as per the service manual.Unit passed all tests.Returned unit to customer for use.

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: 18754337
• MDR Text Key: 336757615
• Report Number: 2249723-2024-00765
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.