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

Model Number N/A

Device Problems Device Emits Odor (1425); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and was able to duplicate the customer's reported issue and noted saline damage was present.At this time, the customer has not produced a purchase order and repairs have been put on hold.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during a routine morning check performed by the customer, when turning on the power, the cardiosave intra-aortic balloon pump (iabp) generated a system failure alarm.The alarm was generated when the console was plugged in and when customer tried to run the iabp unit just on the battery.In addition, a burning wire smell was noted during the event.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp and during testing of the unit observed failure.The stm observed saline penetration on console display cable connector.The stm traced the saline damaged to the power management, pneumatic interface, cab to pim, printer, and printer interface circuit.The stm replaced all damage circuits and corrected failure.Subsequently, the unit passed all functional and safety tests per factory specifications.The iabp was returned to customer and cleared for clinical use.

Event Description

It was reported that during a routine morning check performed by the customer, when turning on the power, the cardiosave intra-aortic balloon pump (iabp) generated a system failure alarm.The alarm was generated when the console was plugged in and when customer tried to run the iabp unit just on the battery.In addition, a burning wire smell was noted during the event.There was no patient involvement, 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: 10420183
• MDR Text Key: 203357269
• Report Number: 2249723-2020-01293
• 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
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1