MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-45

Device Problem No Device Output (1435)

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

Event Date 11/26/2021

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named in is a getinge employee who has different contact details from that of the event site. A contact person at the event site is: ms. (b)(6), nurse, phone: (b)(6), email: (b)(6). Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the cardiosave intra-aortic balloon pump (iabp) unit and found that the thermal printer was the issue. To fix the issue, the fse replaced the printer,thermal,xe-50b,custom (0161-00-0024-04). The fse then performed a full pm with calibration, functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported during preventative maintenance (pm) that the cardiosave intra-aortic balloon pump (iabp) unit could no longer print out ecg results. There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID, TYPE I PLUG
• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13053035
• MDR Text Key: 282629193
• Report Number: 2249723-2021-02917
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No Answer Provided
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse