MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp, for the reported issue "maintenance code 7" powered the iabp on and observed the unit complete and pass all power on self tests.He connected known system trainer and known balloon and initiated autofill, the device completed autofill and continued pumping at 80bpm for approximately 60 minutes without any alarms or abnormal function occurring.He continued troubleshooting and noticed dust on power supply as well as fault #64 in the logs, cleaned power supply per service manual and completed full pm, safety, calibration, and functionality checks.All checks passed factory specifications.Will allow device to run for 24hrs and follow up with customer to ensure unit has not powered off.On 6-17 followed up with biomed and confirmed device was still running after 24hrs without shutting down.Device is functioning in accordance with factory specifications at this time and is cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.The full name of the initial reporter that is abbreviated is (b)(6).

Event Description

It was reported by the customer that prior to in house training the cs300 intra-aortic balloon pump (iabp) had a maintenance error #7 and powered off.There was no patient involvement, and no adverse event reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 12107604
• MDR Text Key: 265584277
• Report Number: 2249723-2021-01427
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.