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

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

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 was dispatched to investigate.The fse evaluated the iabp unit and was able to duplicate the reported issue and found that the retraction issue had caused damage to the outer skin of the power cord.The fse confirmed that the iabp unit could plug into ac power and unlocked the reel and replumbed the power cord.All tests were performed and passed to factory specifications and the iabp unit was returned to the customer f and cleared for clinical service.

Event Description

It was reported that prior to use on a patient while preparing the cardiosave intra-aortic balloon pump (iabp) for use, the power cord was locked in the reel and could only be pulled out 15cm.The power cord could not be stretched, was unable to retract and could not be connected to ac power.The customer had to use a patch panel connection to connect the iabp unit to ac power.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE I PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8557188
• MDR Text Key: 143857282
• Report Number: 2249723-2019-00683
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1