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

Model Number N/A

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.On (b)(6) 2017, a getinge field service engineer (fse) confirmed problem stated by customer that the iabp alarming "power-up test failure code #14".The fse found one of the batteries to be faulty, and when he removed this battery the unit powered up with no issues.The fse ordered the batteries with the intention to return and replace same.Subsequently, on (b)(6) 2017, the fse returned with batteries and replaced both, and upon start up of operation he again received "power-up test failure code #14" once again.The fse then proceeded to replace the motor control board, power distribution board, but the error still persisted.The fse then tried to calibrate the drive pressure regulator, but the pressure would not increase, so he decided to order a scroll compressor to return to the facility and replace.On (b)(6) 2017 the fse returned with the new scroll compressor, disassembled removed and replaced the scroll compressor, then powered up device in service mode and performed all calibrations and functional tests per service manual.When the iabp was turned on, it came on in normal operational mode, and is now working to manufacturer specifications and ready for clinical use.

Event Description

Customer reported a booting up issue of the intra-aortic balloon pump (iabp).The problem was cited as possible power supply/power management board issue.There was no patient involvement and no adverse event reported.

Manufacturer Narrative

Per policy, the replaced scroll compressor was returned to getinge's national repair center (nrc) for further evaluation.Inspection of the scroll compressor was completed with visual damage observed to the wires which are cut and no connector attached to the wires.The scroll compressor could not be tested due to wires that are cut and no connector attached to the wires, and is being retained in the nrc per procedure.

Event Description

Customer reported a booting up issue of the intra-aortic balloon pump (iabp).The problem was cited as possible power supply/power management board issue.There was no patient involvement and no adverse event reported.

Manufacturer Narrative

On 8-11-2017, a (b)(6) field service engineer (fse) confirmed problem stated by customer that the iabp alarming "power-up test failure code 14".The fse found one of the batteries to be faulty, and when he removed this battery the unit powered up with no issues.The fse ordered the batteries with the intention to return and replace same.Subsequently, on (b)(6)2017, the fse returned with batteries and replaced both, and upon start up of operation he again received "power-up test failure code #14" once again.The fse then proceeded to replace the motor control board, power distribution board, but the error still persisted.The fse then tried to calibrate the drive pressure regulator, but the pressure would not increase, so he decided to order a scroll compressor to return to the facility and replace.On (b)(6)2017 the fse returned with the new scroll compressor, disassembled removed and replaced the scroll compressor, then powered up device in service mode and performed all calibrations and functional tests per service manual.The drive regulator was also replaced, and when the iabp was turned on, it came on in normal operational mode, and is now working to manufacturer specifications and ready for clinical use.

Event Description

Customer reported a booting up issue of the intra-aortic balloon pump (iabp).The problem was cited as possible power supply/power management board issue.There was no patient involvement and no adverse event reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6822005
• MDR Text Key: 83858697
• Report Number: 2249723-2017-00348
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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