MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Circuit Failure (1089); Installation-Related Problem (2965)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.Not returned to manufacturer.

Event Description

It was reported by the customer that "mainboard" was booting up as cs300 instead of cs100.It is unknown under which circumstances this event occurred or if there was any patient involvement; however there was no adverse event reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.It was later reported by the customer that mainboard was being replaced due to electrical code # 4 issue.

Event Description

It was originally reported by the customer that the "mainboard" was booting up as cs300 instead of cs100.It was later reported by the customer via a telephone conversation that the cs300 intra-aortic balloon pump (iabp) was booting up as cs100 instead of cs300.There was no patient involvement, and no adverse event reported.

Event Description

It was originally reported by the customer that the "mainboard" was booting up as cs300 instead of cs100.It was later reported by the customer via a telephone conversation that the cs300 intra-aortic balloon pump (iabp) was booting up as cs100 instead of cs300.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A good faith effort attempt was made to the customer and the facility's biomedical engineer reported that they had spoken to getinge tech support who guided them (biomed) to use the iabp's user manual, where it indicates to go into configuration mode and set the iabp from cs100 to cs300.The iabp was then cleared for clinical service.Additional good faith effort attempts have been made to the customer for additional information and no response has been received.If any information is received in the future, we will send a supplemental report.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8896500
• MDR Text Key: 186732685
• Report Number: 2249723-2019-01281
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/16/2020
• Supplement Dates FDA Received: 01/08/2020; 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1