MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ADVANCED MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspection.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

As reported, during a presentation with this hemosphere monitor, a red warning screen was displayed, audible alarms sounded and the electrical plug sparked twice at the back of the device.The monitor was unplugged and, after some time, powered off and continued to alarm.The only cables connected to the monitor during the presentation were the orange electrical cable, pressure controller kit and hemosphere pressure cable.There was no patient involvement.

Manufacturer Narrative

Updated section h6 (component code), h6 (impact code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion) the monitor was first received at the original manufacturer for a full examination.This device was received with an orange power cord.There was no evidence of external liquid residue.Before going through the decontamination process this hem1 and the cord were sent to a failure analysis lab.Based on the lab results evidence of arcing was found between the power cord and the device.There was not any concrete reason found for the arcing, but it was suspected that a piece of foreign object debris (fod) inside the receptacle of the power cord could have caused a poor connection.After the lab returned the device, it was decontaminated and delivered.The device fuses were removed and checked.They were not blown.A known working power cable was connected to the device, and it powered up with no errors and no sparks.Based on product evaluation and investigation done by internal ew complaint engineer, it was found that the power cable used is not a compatible medical grade power cable.The orange electrical cable is not an edwards approved cable.The cable is not a hospital grade.No green dot signifying hospital grade.Additionally, within the connector of the power cord, there is a foreign object debri (fod) found.Upon further review of this fod, it can be observed that it has been charred.This is likely due to the fod being burned off, causing spark based on users complaint.Therefore, the arcing was due to poor connection caused by piece of plastic (fod) found inside the receptacle of the power cord.Complaint could not be replicated.The piece of fod may have been burnt off or clean off, resulting in good connection.Additional testing was done on the monitor using ew approved cable at 120v.Fuses were checked to be good prior to testing and the device is functioning per normal.There was no spark observed.The hemosphere ifu was reviewed and users are warned against using incompatible/unauthorized power cable.An edwards medical grade power cable is required.In conclusion, the root cause is due to user not following ifu and unintended use error based on fod found.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine, ca 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine, ca 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17835220
• MDR Text Key: 324491733
• Report Number: 2015691-2023-16214
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1