MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS18597
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	02/02/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the device did not sound the asystole alarm fast enough.It was further reported the patient died but the connection between the reported event and the patient death could not be clarified yet.
Additional Manufacturer Narrative
The local dräger s&s organization has performed an on-site evaluation of the patient monitor and the central monitoring station.The patient monitor had a mechanical damage of the housing and was equipped with a non-dräger internal battery which was defective or did otherwise not allow operation without mains supply.Besides these non-conformities, monitoring was functional.The logs for the particular monitoring episode had been overwritten already since the device remained in further use.The logs of the central monitoring station had been erased as well.In general, the reported aspect of delayed alarming can neither be confirmed nor denied due to the fact that the information relevant for an assessment was not available.There is however no indication for the potential presence of a device malfunction.The non-conformities observed with the device should have prevented from putting it into use, but these have no relation to the reported event; monitoring was functional when the device was tested in follow-up of the event.Another aspect that substantiates the postulation that no device-related errors have likely occurred during the course of event is that the device was further used afterwards - an operator would probably not do this when significant concerns against the safety and performance of the device exist.A reliable conclusion in regard to the exact root cause for the reported event cannot be made.A number of contributing factors must be taken into consideration while - on the other hand - a differentiation is not possible due to lack of information.For example, if a sensor for a particular monitoring channel becomes detached from the patient (ecg electrodes, spo2 sensor), the device will post a technical alarm.It is in the nature of things that life-threatening conditions which occur in sensor-off condition cannot be detected anymore via this channel; the device will not post physiological alarms.It would also be plausible that a loss of network connection has interrupted the forwarding of alarms to the central station while the alarm posted by the bedside monitor was recognized with delay only.Correction - the initial report was sent under mdr number 2510954-2024-00025 in error.The correct mdr for this submission is: 1220063-2025-00008.After confirmation from the biomed about the event that occurred on february 2nd.It turns out that the doctors have ruled that these were not undesirable events, so there is no reason to question the monitors.The customer is no longer alleging that a malfunction occurred.No further information was provided.

• Brand Name: INFINITY DELTA
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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 ; 9784097390
• MDR Report Key: 21253190
• Report Number: 1220063-2025-00008
• Device Sequence Number: 8206294
• Product Code: MHX
• UDI-Device Identifier: 04049098053457
• UDI-Public: (01)04049098053457(11)20111129(93)7489375
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS18597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2014
• 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