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

Model Number N/A

Device Problems Retraction Problem (1536); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to the customer's site and after evaluating the iabp unit, was able to verify the customer's reported issue.No parts were replaced and the details of the evaluation have been requested.The fse has advised that iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that during use on a patient, the line cord for the cardiosave intra-aortic balloon pump (iabp) was blocked inside the cart and the length was too short to connect to ac power.The customer swapped out the iabp unit with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) reported that the customer had not requested getinge to service the iabp.However, the customer provided repair information to the fse and reported that the customer's biomedical engineer was able to reproduce the reported issue before the repairs.The biomed opened the carter and put back the cord in the reel.The iabp unit was then returned and cleared for clinical use.Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the line cord for the cardiosave intra-aortic balloon pump (iabp) was blocked inside the cart and the length was too short to connect to ac power.The customer swapped out the iabp unit with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F 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: 9179522
• MDR Text Key: 190338456
• Report Number: 2249723-2019-01641
• 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: 11/04/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1