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

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A getinge field service engineer (fse) spoke with cath lab tech, and the customer declined service.The console was not pushed all the way inside of the cart.The tech verified that the batteries were charging.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.No service requested.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would not charge battery number 1.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Additional information was requested from the customer with regard to the repair and status of the iabp.The customer reported that the iapb was not damaged and did not require repair.The iabp was removed from service until the following day when a tech came to inspect it.The transport module had been removed and was not pushed all the way in when it was replaced.The nurse caring for the patient was not aware of that feature, and was educated on how to properly replace the module.The iabp unit was charged immediately when reconnected and had only partly depleted the #1 battery when she discovered it.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would not charge battery number 1.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h4, h6 (type of investigation), h10.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) would not charge battery number 1.No patient harm, serious injury or 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: 11360525
• MDR Text Key: 233260562
• Report Number: 2249723-2021-00343
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1