MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS26800
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that at 2130 it is noted that the telemetry only shows visual alarms, no audible alarm sound is heard, although the sound volume is at 100 percent.It is unclear how long this has been the case.Earlier in the day, the control center for the telemeters was changed.There is no report of any adverse event or patient harm.
Additional Manufacturer Narrative
A complaint was received where the customer stated that the telemetry only showed visual alarms, no audible alarm sound was heard.No adverse patient impact was reported.An ics system with a valid serial number was provided in the record, but the telemetry bedside monitor in use at the time (m540 or m300) was unknown.Attempts to obtain this information along with the exact device where the alarms were not heard, if any messages were displayed at the ics or bedside monitor and what was occurring with the patient at the time of the event, were unsuccessful.The description of event also stated that earlier in the day the control center for the telemeters was changed however, clarification on this was not provided.According to the 05aug24 email response, the issue was resolved immediately after a speaker had a hardware failure and stopped working.It was also stated that it was installed incorrectly relying on a kvm box to connect the audio which is not according to drager recommendations.Attempts were made to determine exactly what hardware failed, what the resolution to the issue was, and if the bedside monitor alarmed as intended; however, this information was not made available.Without further information a root cause of the hardware failure was unable be determined.
Event or Problem Description
The customer reported that at 2130 it is noted that the telemetry only shows visual alarms, no audible alarm sound is heard, although the sound volume is at 100 percent.It is unclear how long this has been the case.Earlier in the day, the control center for the telemeters was changed.There is no report of any adverse event or patient harm.

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 19632542
• Report Number: 1220063-2024-00083
• Device Sequence Number: 8610666
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)231012(93)MS26800-53
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MS26800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown