MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)

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

Event Date 11/25/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A supplemental report will be submitted upon completion of evaluation.Full name of initial reporter: (b)(6).

Event Description

It was reported that during use on a patient, the display of the cardiosave intra-aortic balloon pump (iabp) froze, without any values being displayed and all the information disappeared.The customer turned the iabp unit off and back on again, and the iabp functioned as it should.In addition, the event logs showed fault codes 2/2, 37/2, 55/2, 69/1, 77/24.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Per follow up #1, the executive processor board was sent to the supplier for failure analysis per procedure.Subsequently, the supplier subsequently returned the board to getinge's national repair center (nrc) and advised that they could not verify the failure of the screen freezing without any values being shown and that the board passed testing.The nrc installed the board into a cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual, and the board passed testing.The board was returned to stock per procedure.

Event Description

It was reported that during use on a patient, the display of the cardiosave intra-aortic balloon pump (iabp) froze, without any values being displayed and all the information disappeared.The customer turned the iabp unit off and back on again, and the iabp functioned as it should.In addition, the event logs showed fault codes 2/2, 37/2, 55/2, 69/1, 77/24.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

It was identified that the executive processor board was suspected to be faulty and was therefore returned to getinge's national repair center (nrc) for failure analysis.A technician of the nrc inspected the board with no visual damage observed.The technician then installed the board into the cardiosave test fixture and tested the board to factory specifications per service bulletin and the cardiosave service manual.The nrc could not verify the failure of the screen freezing without any values being shown.The board passed testing, and was sent to the supplier for failure analysis per procedure.The supplier returned the executive processor board to the nrc and advised that they could not verify the failure of the screen freezing without any values being shown.The board passed testing.The technician of the nrc then 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 will be returned to stock per procedure.

Event Description

It was reported that during use on a patient, the display of the cardiosave intra-aortic balloon pump (iabp) froze, without any values being displayed and all the information disappeared.The customer turned the iabp unit off and back on again, and the iabp functioned as it should.In addition, the event logs showed fault codes 2/2, 37/2, 55/2, 69/1, 77/24.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during a routine safety disk change, the getinge field service engineer (fse), entered service mode to update the replacement details and he found the touch screen to be massively out of calibration of cardiosave intra-aortic balloon pump (iabp).The fse attempted to carry out a calibration of the touch screen and was unable.Upon restarting the machine in clinical mode to see what effect all this was having the iabp presented electrical test failure.The fse then ordered a new video generator board and it failed out of box.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F PLG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8180570
• MDR Text Key: 131000652
• Report Number: 2249723-2018-02175
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/11/2019

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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/25/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 05/01/2019; 05/23/2019; 07/11/2019
• Supplement Dates FDA Received: 05/23/2019; 06/21/2019; 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1