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

Catalog Number	UNKNOWN
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); Insufficient Information (4580)
Date of Event	11/11/2019
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 the patient data after a high frequency of 150 bpm was not able to be reviewed in the trend.The customer confirmed that the bedside monitor continued to real time monitoring.The customer reported that the inability to review the historical trend of the event could potentially impact diagnosis and treatment.The user switched out the telemetry unity to amend the issue.No adverse patient impact was reported.
Additional Manufacturer Narrative
A complaint was received where the customer stated that real-time monitoring and alarming for high frequency of 150bpm continued however, the data was not saved in the events in the telemetry monitor for the current patient.No adverse patient impact was reported.The description of event further states that the ward discharged the patient, changed the telemetry box and readmitted the patient which resolved the issue.Attempts to obtain further information including the exact telemetry devices and serial numbers for the devices in use at the time of the event and any changes made to the network or devices prior to the issue, were unsuccessful.According to the(b)(6) 2024 email response, no more information was available.Without further information a root cause of the discrepancy regarding stored data cannot be determined.If more information should become available, a child record associated with this complaint will be opened for proper documentation.
Event or Problem Description
The customer reported that the patient data after a high frequency of 150 bpm was not able to be reviewed in the trend.The customer confirmed that the bedside monitor continued to real time monitoring.The customer reported that the inability to review the historical trend of the event could potentially impact diagnosis and treatment.The user switched out the telemetry unity to amend the issue.No adverse patient impact was reported.

• 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: 19632481
• Report Number: 1220063-2024-00076
• Device Sequence Number: 8793851
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)221018(93)MS26800-50
• 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: Health Professional,User Facility
• 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: UNKNOWN
• 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
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown