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

Model Number N/A

Device Problems Circuit Failure (1089); Failure to Sense (1559); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the iabp and was not able to duplicate the reported failure.Reviewed logs and found failure code 137 (a software fault at the video graphics library) that occurred 6 times.The stm replaced replace the video generator board , and coiled cable to display panel.Further more, it was verified multiple times the batteries.They were switching without and hesitation.Subsequently, the stm performed functional tested without any issues.The cardiosave iabp service was completed.Safety, calibration, and functionality checks passed to factory specifications.The iabp was released to the customer and cleared for clinical use.

Event Description

It was reported that during transport of a patient, the cardiosave intra-aortic balloon pump (iabp) switched from low battery to full battery, in addition the unit shut down and alarmed.The customer was able to restart the unit with a full charged battery.There was no harm or injury to the patient and no adverse event was reported.

Event Description

It was reported that during transport of a patient, the cardiosave intra-aortic balloon pump (iabp) switched from low battery to full battery, in addition the unit shut down and alarmed.The customer was able to restart the unit with a full charged battery.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: 10852714
• MDR Text Key: 216657209
• Report Number: 2249723-2020-01922
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1