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

Catalog Number	MS18597
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported to draeger that the delta monitor did not start up after a power failure at the customer's site.A draeger technician isolated the issue to a faulty infinity docking station (ids) and the power supply in use with the delta monitor.These faulty components were replaced at the customer site to resolve issue.The devices were tested with the delta monitor, and they were returned to use with no failures found.It was reported that no patient or employee had been in contact with the delta monitor as it was not yet put into use for monitoring.There was no information provided regarding testing or findings on the failed ids and power supply.There was no injury initially reported in the complaint description.The user facility report provided, documented that there was a report of an employee who received an electrical shock.This occurred when the patient monitor was being placed on the ids that triggered the current circuit breaker to trip.Several requests were made for information regarding the employee who received an electrical shock but despite our best-efforts it was not provided.The details regarding the severity of the shock and if any medical treatment was necessary could not be determined.There have not been any additional reports of malfunctions from this customer's site.The power supply in use, is designed to meet ul2601-1:1997 and iec60601- 1: 1 988/al: 19931 a2: 1995 iec/en) standards.
Event or Problem Description
The customer reported a power failure in a ward and that a delta monitor was no longer starting up.The monitor was also not in operation and no patient or employee had been in contact with it.On (b)(6) 2024, a ufr was received stating that an employee had been shocked when placing the delta on the docking station, triggering the station's circuit breaker.No details regarding the electric shock were provided, and no report of patient death was reported.
Event or Problem Description
The customer reported a power failure in a ward and that a delta monitor was no longer starting up.The monitor was also not in operation and no patient or employee had been in contact with it.On may 03 2024, a ufr was received stating that an employee had been shocked when placing the delta on the docking station, triggering the station's circuit breaker.No details regarding the electric shock were provided, and no report of patient death was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.

• Brand Name: DELTA
• Common Device Name: PHYSIOLOGIC 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 19310617
• Report Number: 1220063-2024-00052
• Device Sequence Number: 3063294
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)200310(93)MS18597-68
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/05/2024

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 Catalogue Number: MS18597
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown