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

Model Number N/A

Device Problems Failure to Charge (1085); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue found significant traces of salt on the surface as well as inside the device after spilled saline.The device detected the presence of mains voltage but could not be started.An electronic fault was detected by the measurement boards (power supply monitor board) for controlling the power supply of the device.The pm included the replacement of the safety disk and the tidal volume disk.The device is not working.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.

Event Description

It was reported that during the inspection, the cardiosave transport module mount would not charge the batteries.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) would not charge the batteries.It is unknown under which circumstances the event occurred or if a patient was involved.However there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed that the iabp unit was infested with saline which was indicated by white traces of salt on the walls and bottom of the card after the console had been pulled out.It was noted that the iabp unit could not be switched on even after the 230 vac mains voltage was connected.Further troubleshooting revealed a non-functional power supply monitor board.The measured value of the output voltage at the power supply terminals was 2.3 vdc.The fse disconnected the j1 connector on the power supply monitor board and observed a voltage value of 15.1 vdc measured at the power supply terminals.The fse recommended the customer replace the power supply monitor board.The fse completed pm service on the iabp unit, however, the iabp unit was not cleared for use.Subsequently, the fse returned to the customer's site at a later date and replaced the power supply monitor board.The iabp unit was observed to turn on.The fse then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.Updated fields: b4, g4, g7, h2, h6 (evaluation result codes, evaluation conclusion codes) h10, h11 corrected fields: a1, a3, b5, d1, h6 (patient codes, device codes), h10.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h4, h6 (type of investigation), (component codes), h10.

• Brand Name: CARDIOSAVE HYBRID TYPE E/F 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: 11345020
• MDR Text Key: 232859726
• Report Number: 2249723-2021-00326
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• 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
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.