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

Model Number N/A

Device Problem Failure to Charge (1085)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service technician (fse)reported that cardiosave cannot charge battery sometimes. The fse replaced exch pcb, power management, rohs (0670-00-1162 ) and the unit was working and was able to charged the battery. Performed all functional and safety checks to meet factory specifications. The iabp was return to customer and cleared for clinical use.

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) does not charge the battery sometimes. There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B 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: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11518521
• MDR Text Key: 240961643
• Report Number: 2249723-2021-00557
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Reuse