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

DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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Model Number N/A

Device Problems Mechanical Problem (1384); Device Emits Odor (1425); Device Displays Incorrect Message (2591)

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

Event Date 07/03/2018

Event Type malfunction

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.Additional information has been requested.A supplemental report will be sent upon receiving this information.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) suddenly turned standby mode and the touch panel could not be used.Error code#13 was being displayed.The pump was replaced to continue therapy.It was noted that the pump had a burnt smell a bit.No patient injury was reported.

Manufacturer Narrative

A getinge field service engineer was dispatched to investigate.The fse evaluated the iabp and found that the printer interface board inside the iabp was burned and the c8 capacitor was punctured.The fse opted to replace the power management board and printer interface board.The fse ran tests on the iabp and the reported failure did not reoccur.In addition, a fluid adhesion was seen on part of the recorder (lower right corner), but there were no other stains on any other area of the iabp.The fse advise that he will return the removed parts to the getinge national repair center for further investigation as they were unable to find the root cause of the damage to the power management board and printer interface board.The iabp will not be released for clinical use until the part investigation has been completed.A supplemental report will be submitted when additional information is made available.

Event Description

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.The power management board and printer interface board were received by the getinge national repair center (nrc) for further investigation.A technician of the nrc inspected the power management board per procedure with no visual damage observed.Inspection of the printer interface board was completed with visual damage observed to component c6 which was badly burned along with smoke damage to surrounding components.The technician installed the power management board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual.The board would not boot up when the console was in the cart.Also, the unit would not power down in the cart.The board failed testing.The power management board was sent to the supplier for failure analysis per procedure and upon the inspection of the board per procedure the installation of the rework is required.The technician of the nrc reported that the printer interface board could not be tested due to burned component c6.The board would was be retained in the national repair center per procedure.

Event Description

Manufacturer Narrative

A getinge service representative reported that the iabp was finally returned to the customer and clear for clinical use.In addition, when this iabp unit was returned to the facility, the customer was asked to perform regular check of this iabp unit every month.Moreover, our fse will visit for routine preventive maintenance to the facility as well.No further investigation is required.

Manufacturer Narrative

Follow-up 2 was missing and should have been submitted with date 22-jan-2019.The supplier returned the power management board to the getinge national repair center (nrc).The supplier reported that they have verified the failure of ¿the console would not shut off in cart and the console would not boot up in the hospital cart¿.The supplier replaced q33 and q35.The board passed testing.Inspection of the power management board was performed by a technician of the nrc and completed per procedure with no visual damage observed.Upon inspection of the board per procedure, the required rework was observed.The technician of the nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual.The board passed testing and was sent to stock per procedure.

Event Description

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields: h10 (of follow up #2).There was a typo in the h10 of follow-up #2.The narrative should have been reported as follows: the power management board and printer interface board were received by the getinge national repair center (nrc) for further investigation.A technician of the nrc inspected the power management board per procedure with no visual damage observed.Inspection of the printer interface board was completed with visual damage observed to component c8 which was badly burned along with smoke damage to surrounding components.The technician installed the power management board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual.The board would not boot up when the console was in the cart.Also, the unit would not power down in the cart.The board failed testing.The power management board was sent to the supplier for failure analysis per procedure and upon the inspection of the board per procedure the installation of the rework is required.The technician of the nrc reported that the printer interface board could not be tested due to burned component c8.The board would was be retained in the national repair center per procedure.

Manufacturer Narrative

Update fields: b4, g4, g7, h2, h10.As per the getinge standard operating procedure, a getinge company representative has provided the customer with information related to the investigation of this complaint, including the outcome of the manufacturer and supplier analysis.The customer has advised that due to their dissatisfaction with the results, they will delay in releasing the iabp unit for clinical use.No expected date has been provided.At this time, no further action is required by the manufacturer.A supplemental report will be submitted if additional information becomes available.

Event Description

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Brand Name

CARDIOSAVE

Type of Device

SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Manufacturer (Section D)

DATASCOPE MAHWAH

1300 macarthur blvd.

mahwah NJ 07430

MDR Report Key

7742962

MDR Text Key

116057348

Report Number

2249723-2018-01303

Device Sequence Number

Product Code

DSP

Combination Product (y/n)

PMA/PMN Number

K112372

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative,foreig

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

08/02/2018

Is this an Adverse Event Report?

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Model Number

N/A

Device Catalogue Number

0998-00-0800-XX

Device Lot Number

N/A

Was Device Available for Evaluation?

Yes

Device Age

Date Manufacturer Received

03/12/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

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

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