MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH SYS 98XT, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-UC-0479-67

Device Problem Use of Device Problem (1670)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213).A getinge field service engineer (fse) was dispatched to evaluate this unit and after troubleshooting, the fse replaced the ac cable cord.Upon completion of our investigation, a supplemental report will be submitted.The full name of the initial reporter was shortened due to field character limit; the full name is: (b)(6).

Event Description

It was reported that the sys 98xt, (b)(6), 220v intra-aortic balloon pump (iabp) is out of service.No specific malfunction was reported.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

• Brand Name: SYS 98XT, ITALIAN, 220V
• 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: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12174985
• MDR Text Key: 261754787
• Report Number: 2249723-2021-01530
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K961509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-UC-0479-67
• Device Catalogue Number: 0998-UC-0479-67
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1