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

Model Number N/A

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) has advised that when calling the customer to schedule a repair, the customer stated they wanted to cancel the service request.The customer reported that after rebooting the iabp unit, calibration of the touchscreen was able to be performed.The customer has not requested for getinge to evaluate the iabp unit involved.Additional information is being requested to obtain the current status of the iabp unit.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that the touchscreen for the cardiosave intra-aortic balloon pump (iabp) was unable to be calibrated.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Event Description

It was reported that while the cardiosave intra-aortic balloon pump (iabp) unit was in the biomed shop for a routine check, the touchscreen was unable to be calibrated.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, b5, e1 (event site email), g4, g7, h2, h10.Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.The customer reported that this service request was cancelled due to the issue being resolved in house.No further investigation is required.

• 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: 9521264
• MDR Text Key: 191404758
• Report Number: 2249723-2019-02085
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1