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

Model Number N/A

Device Problems Failure to Run on Battery (1466); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was working properly but remained in battery mode despite trying different outlets and clicking it in and out of the cart multiple times.After discussion with the clinician, the customer was advised swapping out the pump which the customer did.In addition, customer was recommended to take the pump out of service and have biomed look at it.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the power supply, and performed a full preventive maintenance (pm) with all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was working properly but remained in battery mode despite trying different outlets and clicking it in and out of the cart multiple times.After discussion with the clinician, the customer was advised swapping out the pump which the customer did.In addition, customer was recommended to take the pump out of service and have biomed look at it.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was working properly but remained in battery mode despite trying different outlets and clicking it in and out of the cart multiple times.After discussion with the clinician, the customer was advised swapping out the pump which the customer did.In addition, customer was recommended to take the pump out of service and have biomed look at it.There was no harm or injury to the patient and no adverse event was 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: 10258288
• MDR Text Key: 198489644
• Report Number: 2249723-2020-01055
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1