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

Model Number UNKNOWN

Device Problems Crack (1135); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that a patient was being monitored with an infinity delta patient monitor connected to a hemomed pod (part # 5588822, serial # (b)(6).The hemomed malfunctioned.The patient was resuscitated.

Manufacturer Narrative

Several attempts had been made to acquire additional information regarding this event.Dräger was unable to obtain further information in regard to the course of event, if other vital parameter were monitored or not and what exactly has led to the circumstances that made the patient¿s resuscitation necessary.Logs from the delta patient monitor and from the central monitoring station (ics) as well as the hemomed pod and cable were returned to draeger for evaluation.The log consists of two sections ¿ the event log which captures readings and physiological alarms and the error log that which captures the entries of technical events.The event log did not contain relevant data anymore because the patient had been released.This is normal device behavior to delete all entries when a user executes the patient release.Furthermore, the error log was erased as well.The logs for the ics indicate that none of the connected bedside monitors were offline during the period in question, further details could not be derived from the log.The delta patient monitor was tested by a third-party service provider who stated to dräger that no major deviations were detected.The only aspect mentioned as a side note was that an ibp label was displayed on the delta screen despite there was no ibp measurement active.The hemomed pod is the device that reads the ibp patient signal and transmits the data to the delta patient monitor.The pod exhibited a clearly visible housing damage resulting in loose parts inside.Furthermore, a damage at the pressure input ports was observed.The pod was not recognized by a delta patient monitor once it was connected to the lab device.The delta can be configured to automatic recognition of connected devices/pods during the start-up procedure.For example, if a hemomed pod is connected and recognized by the delta, a dedicated label will appear on the screen.The parameter box will only display values and curves if this monitoring channel is active and functional.The reported observation of blank ibp label with a pod connected is not necessarily related to malfunction.Dräger concludes the following: it is unknown when exactly the pod damage has occurred ¿ before the concerned monitoring episode, during or after.A presence before start of use is unlikely since the pod was non-functional which will become obvious during set-up for use and, visual appearance of the product should have prevented from using it.An occurrence during use may have manifested during operator intervention for resuscitation of the patient and thus, may not necessarily have contributed to the event.Due to the empty logs for the delta, it cannot be determined if physiological alarms were posted during the event.When the readings of an activated monitoring channel get lost, the delta is designed to post a technical alarm.Since it was reported by the third-party service provider that the delta did not exhibit any deviations in follow-up of the event, dräger concludes that the signal loss alarms for the individual channels work according to specification.The instructions for use (ifu) contain a warning that therapeutical decisions must not be made on the base of one single vital parameter.Furthermore, it is essential that the user also responds in a timely manner to low-priority technical alarms (signal loss).Finally, among the available information there was no clear indication found that a technical error condition of the involved dräger devices has caused or contributed to the event.

Event Description

It was reported that a patient was being monitored with an infinity delta patient monitor connected to a hemomed pod.The hemomed malfunctioned.The patient was resuscitated.

• Brand Name: INFINITY DELTA / DELTA XL
• Type of Device: 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
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 16957791
• MDR Text Key: 315531008
• Report Number: 1220063-2023-00015
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention