MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DATABASE REL N.0

Model Number 865436

Device Problem Delayed Alarm (1011)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that there was latency of the alarms reading at the level of the central station.It is unknown if the device was in use at time of event, and there was no adverse event reported.

Manufacturer Narrative

Additional information was received, which confirmed there was no patient incident.Information also indicated a similar issue also occurred in another room.This additional issue has been reported on mfr report number 1218950-2024-00025.A good faith effort (gfe) request was made for log files and the central station log files were provided.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the patient information centre xi (pic) indicating that there was latency of the alarms reading at the level of the central station.The device usage at the time of the event is unknown.No adverse event occurred.The following functional tests, good faith effort (gfe), technical investigation and communication were performed and confirmed latency of alarm reading at the control panel.The remote service engineer informed that this track corresponded to the ch245 where an spo2 alarm low to 70% would not have sounded and would have sounded only at 89% going up.The rse retrieved the logs from the control panel, checked the configuration of arrhythmia alarms at the control panel, checked the configuration of alarms on a monitor, spo2, arrhythmia.The rse informed that the customer had not had a trace for ch 246 and ch247 and had not had any information on the spo2 setting since the file was opened.The complaint was escalated for technical investigation.A philips product support engineer (pse) evaluated the following documents: alarm log, configuration file picture and technical logs.As per pse, from the alarm log during the time of event no information from the bed ch247 was present, probably the alarms is disabled.Since could not get the monitor configurations at the time of event could not provide more details on the issue.Alarm logs: 17:28:54.515 (b)(6) /2023 : dataserver, ch247, lbn 32, arrhythmia analysis off! 17:28:57.250 (b)(6) /2023 : dataserver, ch247, lbn 32, arrh alarms on.17:28:59.296 (b)(6) /2023 : dataserver, ch247, lbn 32, alarms suspended.17:28:59.484 (b)(6) /2023 : dataserver, ch247, lbn 32, arrhythmia analysis on! 17:29:51.546 (b)(6) /2023 : dataserver, ch247, lbn 32, alarms not suspended.17:29:59.953 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:30:00.906 (b)(6) /2023 : sdprocess, ch247 alarm ***tachy 143 > 140.17:32:56.000 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:32:56.140 (b)(6) /2023 : sdprocess, ch247 alarm ***tachy 159 > 140.17:33:01.250 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:33:10.500 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:33:17.500 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:33:18.171 (b)(6) /2023 : sdprocess, ch247 alarm ***tachy 144 > 140.17:33:25.750 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.17:33:34.000 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.No information from bed ch247 inbetween (maybe alarms disabled?) 19:26:58.812 (b)(6) /2023 : dataserver, ch247, lbn 32, alarms suspended.19:27:16.234 (b)(6) /2023 : dataserver, ch247, lbn 32, alarms not suspended.21:23:47.906 (b)(6) /2023 : dataserver, ch247, lbn 32, arrh alarms off.21:25:51.859 (b)(6) /2023 : dataserver, ch247, lbn 32, arrh alarms on.00:28:10.765 (b)(6) /2023 : sdprocess, ch247 red alarm sound -bed.00:28:11.546 (b)(6) /2023 : sdprocess, ch247 alarm *** tachy vent.00:28:13.468 (b)(6) /2023 : sdprocess, silenced ch247 *** tachy vent.00:28:13.578 (b)(6) /2023 : sdprocess, silenced ch247 *** tachy vent.Based on the information available and the testing conducted, the reported problem was not confirmed due to insufficient information.Philips was unable to confirm the final disposition of the device because the customer had not had a trace for ch 246 and ch247 and had not had any information on the spo2 setting.If additional information is received the complaint file will be reopened.

• Brand Name: M3150 INFO CNTR LOCAL DATABASE REL N.0
• Type of Device: M3150 INFO CNTR LOCAL DATABASE REL N.0
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18228786
• MDR Text Key: 329260575
• Report Number: 1218950-2023-00892
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

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: 865436
• Device Catalogue Number: 865436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/19/2023; 01/22/2024
• Supplement Dates FDA Received: 01/12/2024; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1