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

Model Number N/A

Device Problem Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) spoke with the customer and asked them to check if the unit was properly seated in the cart and to look at the battery charge indicator to ensure it was operating in ac mode.The customer stated that the unit was not latched into the cart all the way originally.After the customer checked and reinserted the unit into the cart, it was running on ac and charging the batteries.The iabp was then functional tested without any further failures with all safety, calibration, and functionality checks to factory specifications.The iabp was released to customer and cleared for clinical use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had no a/c power and would only run on batter power.It is unknown under which circumstances the event occurred or if a patient was involved, however, there was no adverse event reported.

Manufacturer Narrative

Corrected fields: h6 (patient codes, evaluation result codes, evaluation conclusion codes).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had no a/c power and would only run on batter power.There was no adverse effect on patient.

• 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: 10493222
• MDR Text Key: 205905637
• Report Number: 2249723-2020-01428
• 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
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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?: Yes
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1