MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted.A getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse was able to confirm the reported issue.The touch panel was broken and inactive, the origin of the cracks seems to be the lower left corner of the keypad.No impact hole or bump on the keypad area, the surface is smooth.The display works normally.The fse carefully dismounted the keypad.There is a very clear trace of impact in the lower left corner, but out the area reachable by the users.The fse checked the housing, no trace of impact or solid shock on the surface.Same thing for the upper display housing.A loaner was provided to the customer until cardiosave was repaired.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during the morning control, the customer noticed a that the keypad of the cardiosave intra-aortic balloon pump (iabp) had a "broken screen", the keypad was not active.It is unknown if there was any patient involvement; however there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6, h10.The getinge field service engineer (fse) that started the repairs reported that the touchscreen assembly was replaced and calibrated it to fix the reported issue.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all 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 that during the morning control routine check, the customer noticed that the keypad of the cardiosave intra-aortic balloon pump (iabp) had a "broken screen", the keypad was not active.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during the morning control routine check, the customer noticed that the keypad of the cardiosave intra-aortic balloon pump (iabp) had a "broken screen", the keypad was not active.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9532343
• MDR Text Key: 190502356
• Report Number: 2249723-2019-02118
• 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,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1