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

Catalog Number MS18597

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The customer reported that, during patient monitoring, the delta did not alarm during a patient's desaturation.The reported event occurred in an icu on feb 12, at 1400.There is no information stating there is any adverse patient impact.

Manufacturer Narrative

The investigation was started; results will be provided in a follow up-report.H3 other text : 101202.

Manufacturer Narrative

A complaint was submitted where it was reported that the delta monitor did not alarm when the patient became desaturated.Draeger service engineering reviewed the images of the delta logs that were provided.These logs were determined to be inconclusive.The delta logs did not log any spo2 events based on the reported date and time of the event.The lower spo2 lower limit was set to 88 and the logs do show readings of spo2 <88% at various times well after the reported time of event.To further investigate into these times additional logs and information were requested but could not be provided.It was reported that the biomed saw an entry in the delta logs that someone had silenced an alarm but further information regarding this statement could not be provided.These inadequate logs do not make it possible for the investigation to continue and therefore a root cause for the reported event was unable to be determined.If the reported issue reoccurs in the future it is requested to provide the logs from all the involved devices along with as much information as possible.

Event Description

The customer reported that, during patient monitoring, the delta did not alarm during a patient's desaturation.The reported event occurred in an icu on (b)(6) at 1400.There is no information stating there is any adverse patient impact.

• Brand Name: DELTA
• 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 ; 2156602400
• MDR Report Key: 18921326
• MDR Text Key: 337867891
• Report Number: 1220063-2024-00030
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)101202(93)MS18597-09
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MS18597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2011
• 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
• Treatment: N/A.; N/A.
• Patient Outcome(s): Other