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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The power management board will be returned to the national repair center (nrc) for further evaluation. A supplemental report will be provided.

Event Description

It was reported by the customer that the cardiosave intra-aortic pump is not recognizing ac power when plugged in. It is unknown the circumstances in which the event occurred or if there was patient involvement. However, there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue, the batteries were depleted and not charging. The fse found the power management board to be faulty and replaced it to resolve the issue. The fse verified proper operation of the unit and battery charge and performed full preventative maintenance(pm). The iabp passed all calibration, functional, and safety checks to factory specifications. The unit was returned to the customer and cleared for clinical use. The suspected faulty power management board was sent to getinge's national repair center (nrc) for evaluation. A senior repair technician inspected the power management board and found physical damage to q27. The technician then installed the power management board into cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it failed testing. The national repair center verify the reported failure "batteries do not charge while connected to ac power when pump console is in the cart. ". The power management board was being sent to the supplier per procedure. A supplemental report will be submitted when additional information is provided.

Event Description

It was reported by the customer that the cardiosave intra-aortic pump is not recognizing ac power when plugged in. It is unknown the circumstances in which the event occurred or if there was patient involvement. However, there was 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 07430
• MDR Report Key: 10017317
• MDR Text Key: 189651467
• Report Number: 2249723-2020-00695
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No