MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC GAMMA XL; PHYSIOLOGICAL MONITORING SYSTEM

Model Number	MS18985
Medical Device Problem Codes	False Positive Result (1227); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿at the t2-10 site, we sedated the risk patient somewhat.The saturation meter in the cardio version vibrated and stopped showing the reading value.Showed a good curve, but no reading during the entire sedation.In the end, a finger sensor was used.It would have been important because the patient was obese, started breathing badly and fast.A clear danger event.In addition, at the same place and place t2-9 has increasingly started occur that when the monitor is on, you disconnect the ekg and put it back on, it shows a straight green line for quite a long time before starts showing complexes sometimes causing asy alarms for nothing.There is a fix for the spo2 issue, switching to another technique.This was left undone even during supervision for financial reasons.¿ no adverse patient impact was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
The involved patient monitor was sent to the german dräger repair center after some unsuccessful attempts to download the log file.The log consists of two sections ¿ the event log which captures readings and physiological alarms and the error log which captures the entries of technical events.An in-depth evaluation in the repair center revealed that the event log was completely empty and, the error log did not cover the period in question.Further inspection of the device could determine that the battery that buffers the memory for the alarm log was at 0.5 volts instead of 3 volts (correct voltage).This explains why the event log was empty - the device could not store any data in the log due to the depleted battery.Beyond that, the device has a typical appearance of a product that has been used for 13 years; no functional restrictions have been observed.The user's report is not very precise with room for misinterpretations; a clarification was not possible.The description of event was however the only base for the evaluation since the device was not able to record any data in the log file due to the worn battery that buffers the memory chip.In consequence, the reported phenomenon cannot be clearly understood and neither be confirmed nor denied.Draeger derives from the description of event that the initially intended method of spo2 monitoring did not work whereupon the user introduced a finger sensor; this finger sensor has then provided readings as required.It is not plausible that - for the situation described before the change of the sensor - a curve will be displayed on the screen for spo2 but no numeric values.If the monitor is not able anymore to detect a valid signal for a certain parameter, the respective parameter box will blank out or show "***", the curve will disappear and, an advisory alarm will be generated to alert the user that this channel of monitoring got lost.It would be against clinical practice to make therapy decisions solely on the base of one single vital parameter - the user has to find additional indicators to evaluate the patient status.The aspect in the user's report of patient being sedated could be an indication that the observations were made during a surgical procedure for which it would be mandatory to have patient gas monitoring in place.Further, an anesthesia device must be operated under constant supervision of a trained user whereby the absence of monitoring data would be recognized immediately.Dräger comes to the conclusion that the reported event does likely not incorporate a previously unidentified or falsely assessed risk.
Event or Problem Description
It was reported that ¿at the t2-10 site, we sedated the risk patient somewhat.The saturation meter in the cardio version vibrated and stopped showing the reading value.Showed a good curve, but no reading during the entire sedation.In the end, a finger sensor was used.It would have been important because the patient was obese, started breathing badly and fast.A clear danger event.In addition, at the same place and place t2-9 has increasingly started occur that when the monitor is on, you disconnect the ekg and put it back on, it shows a straight green line for quite a long time before starts showing complexes sometimes causing asy alarms for nothing.There is a fix for the spo2 issue, switching to another technique.This was left undone even during supervision for financial reasons.¿.No adverse patient impact was reported.

• Brand Name: GAMMA XL
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784470587
• MDR Report Key: 17391685
• Report Number: 1220063-2023-00022
• Device Sequence Number: 6770558
• Product Code: MHX
• UDI-Device Identifier: 04049098003865
• UDI-Public: 04049098003865
• Combination Product (Y/N): N
• PMA/510(K) Number: K053484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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 Model Number: MS18985
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2010
• 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
• Patient Sex: Unknown