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

Model Number N/A

Device Problems Failure to Charge (1085); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use on a patient, the cardiosve intra-aortic balloon pump (iabp) experienced power issues and was not charging even when plugged into ac power.A clicking noise was reported to be heard when the iabp unit was plugged into ac power for five minutes, then the iabp unit would turn off.There was no patient harm and no adverse event was reported.

Event Description

It was reported that before use on a patient, the cardiosve intra-aortic balloon pump (iabp) experienced power issues and was not charging even when plugged into ac power.Staff noticed electrical smell.A clicking noise was also reported to be heard when the iabp unit was plugged into ac power for five minutes, then the iabp unit would turn off.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The iabp was not charging, the power supply was not functioning, the batteries had no charge, and the power supply was making a clicking noise in cart.The fse was able to eliminate rescue as problem source by testing it in known working cart without issue.The power supply and monitor board were replaced.The batteries were also replaced but as a precautionary measure, as the power supply issue could damage batteries.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The faulty parts were requested to be sent back for failure investigation.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during a pre use check and prior to use on a patient, the cardiosve intra-aortic balloon pump (iabp) experienced power issues and was not charging even when plugged into ac power.A clicking noise was reported to be heard when the iabp unit was plugged into ac power for five minutes, then the iabp unit would turn off.It was later reported that the hospital staff had noticed an electrical smell.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

The faulty power supply monitor board was returned to getinge's national repair center (nrc) for failure investigation.A getinge technical associate inspected the power supply monitor board per the cardiosave service manual and visual damage was observed through a microscope with the observation of a white substance on the board.It was noted that based upon past experience, the residue was consistent with saline.Additionally, the cart bulk power supply was inspected per the cardiosave service manual and damage was also observed.The components under component tx5 were observed to be burnt.The cart bulk power supply was damage beyond testing.It was noted that the issue was also caused from saline dripping onto the power supply.The nrc has confirmed that the reported issue was caused by a saline spill.The power supply monitor board and cart bulk power supply would be retained in the nrc per procedure.

• Brand Name: CARDIOSAVE HYBRID TYPE B 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: 10712256
• MDR Text Key: 212320568
• Report Number: 2249723-2020-01730
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1