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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse inspected the iabp and found fault code #78, 112, 116 in service logs.It indicates that connection was lost between the display and console during the event.Salt deposit was also found in the coiled cable connection part of the console.Coiled cable and coiled cord to backplane cable were replaced.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that during intra-hospital transport while on a patient, the display on the cardiosave intra-aortic balloon pump (iabp) went blank and an alarm sounded.The iabp was changed for another.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during intra-hospital transport while on a patient, the display on the cardiosave intra-aortic balloon pump (iabp) went blank and an alarm sounded.The iabp was changed for another.There was no harm or injury to the patient and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID INT TYPE G 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: 9900870
• MDR Text Key: 186008965
• Report Number: 2249723-2020-00525
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1