MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. TELEHEALTH CENTER PRODUCT LICENSE; ECAREMANAGER

Catalog Number	865325
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2024
Type of Reportable Event	Death
Event or Problem Description
Customer reported to philips that, the bedside nurse pushed the elert button, but no alert was received remotely and the patient subsequently passed away.
Additional Manufacturer Narrative
Investigation is in progress.However, initial investigation identified that the elert system is not the primary notification system.Gathering of all required information is pending and all the details will be provided in final report.
Additional Manufacturer Narrative
The legal manufacturer in section d2 and g1 was mentioned as visicu, inc (previous lm - address - 217 east redwood st.Suite 1900, baltimore, md, 21202) instead of philips medical systems nederlands b.V (updated lm - address - high tech campus 36, eindhoven, netherlands, 5656ae).During the internal review of the record, it was noticed and hence submitting the correction mdr.Sections d2 and g1 are updated in this report.
Additional Manufacturer Narrative
Device evaluation results are updated in section: d3, f7, g1, g6, h2, h3 & h6.Investigation summary: this report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the ecaremanager indicating that the bedside nurse pushed the alert button, but no alert was received remotely and the patient subsequently passed away.Additional information states that initially the button was not fully depressed, but several minutes later, the button was actually pushed, then the remote nurse connected and worked with the bedside team.The complaint was escalated for technical investigation and the remote service engineer discussed this issue with the customer.It was confirmed by the customer that the alert button had been tested multiple times and it was working.The customer mentioned that the issue likely was caused by the button not being fully pressed during the reported event.The buttons are mechanical, and it's been seen in the past that the mechanism doesn't trigger the notification if they're not fully pressed.Further philips remote service engineer reviewed software and logs, it showed no errors or abnormalities within the event timeline.All alerts query were also pulled for the identified bed and found that there were two confirmed alerts received but not at the time of the incident.Hence, it was confirmed that the button was physically working as customer informed, and it was not fully depressed during the incident resulting in the failure of notification trigger.The customer worked with the staff to investigate the button for failure, and confirmed the button was working properly in all of their testing.There have been no further instances of alert button failure with this or any other room.Thus, the incident was determined to be a case of human error, as the user did not fully depress the button.The ecaremanager is a tertiary notification system and it¿s not intended to be used as a replacement for nurses at the bedside.The alert is a third-party device supplied by a/v vendor and as per ecaremanager 4.5.0 clinical user guide rev.D, section: third-party equipment and technology, it clearly stats that instructions for the care and maintenance of this equipment is the responsibility of the vendor.Even if the alert button experienced a mechanical failure, it will never result in a patient death given our intended use and ifu statements.The ecaremanager system alert call button is an alternate communication tool and it is strongly recommended that the bedside clinicians follow the established protocol if the alert is not acknowledged in a timely manner.However, the device was confirmed to be operating per specifications and there was no evidence of failure of ecaremanager and alert button.Good faith efforts for additional information were performed but further information was not received.Therefore, based on subsequent testing and use of the alert call button, software and log review, the device was found to be worked as designed, without malfunction.Therefore, although a patient death was reported with limited clinical details, the death is unrelated to the ecaremanager system.The cause of the reported problem was user error.Risk assessment has been performed and deemed as acceptable as per the risk management matrix.Based on all the information available and results of additional analysis, no further action is necessary at this time.
Additional Manufacturer Narrative
Sections d4 and g4 are updated in this report.In section g4, k012171 was mentioned as 510k number instead of k211046.Updated as k211046.In section d4, (b)(4) was mentioned instead of (b)(4).Updated as (b)(4).During the internal review of the record, it was noticed.Hence data is corrected and submitted for update.

• Brand Name: TELEHEALTH CENTER PRODUCT LICENSE
• Common Device Name: ECAREMANAGER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; suite 1900; eindhoven MD 5656A E; NL 5656AE
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; high tech campus 36; suite 1900; eindhoven MD 5656A E; NL 5656AE
• Manufacturer Contact: sunil shenoy ; high tech campus 36; suite 1900; eindhoven, MD 5656A-E ; NL 5656AE
• MDR Report Key: 20607982
• Report Number: 1125873-2024-00002
• Device Sequence Number: 20685623
• Product Code: MSX
• UDI-Device Identifier: 00884838102910
• UDI-Public: 00884838102910
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 865325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 11/27/2024; 12/10/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/22/2024; 12/04/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown