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

Model Number	N/A
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	02/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, to provide power to a monitor with low battery, the nurse received an electric shock to the right hand while plugging the m540 into the m500.The m540 immediately disconnected from the patient, and a leakage current alarm went off in the room.The powercord was found to have some burn marks.The nurse felt a tingle numbness in the right hand.They visited the er where vitals taken there for follow-up, ekg, tnt and ck showed normal.During the evening at home on the right side of the body (arm and leg) numbness impotence of knowledge.The next morning the feeling stronger, but then subsided later the next day.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
Further information was provided from the complainant confirming that the nurses condition continued to improve, and no treatment or sustaining injury was reported.The hospital electrician measured the wall socket power and verified the earth ground, line and neutral readings were acceptable.It was not known if the nurse was holding anything else in her other hand or leaning on anything while plugging the device in.The hospital believes it was the m540 that caused the leakage current alarm from their external line power monitoring device.The m540 and m500 devices as well as the associated accessories including the power cord, ecg leads cable, ecg extension cable, desktop power supply, docking station y adaptor, nellcor finger sensor with cable were returned for analysis.Through visual inspection, the reported burn mark on the power cord was confirmed.However, the power cord was tested and confirmed to be functional.During analysis, the reported issue could not be reproduced, no device malfunction was found.The m500 pin plate was updated to current revision, 24.As no device malfunction was identified, root cause could not be determined.
Event or Problem Description
It was reported that, to provide power to a monitor with low battery, the nurse received an electric shock to the right hand while plugging the m540 into the m500.The m540 immediately disconnected from the patient, and a leakage current alarm went off in the room.The powercord was found to have some burn marks.The nurse felt a tingle/numbness in the right hand.They visited the er where vitals taken there for follow-up, ekg, tnt and ck showed normal.During the evening at home on the right side of the body (arm and leg) numbness/ impotence of knowledge.The next morning the feeling stronger, but then subsided later the next day.

• Brand Name: INFINITY ACUTE CARE SYSTEM
• 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 ; 2156602400
• MDR Report Key: 18950389
• Report Number: 1220063-2024-00031
• Device Sequence Number: 7084507
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)200210(93)MS26372-53
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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 Model Number: N/A
• Device Catalogue Number: MS26372
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• 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: Required Intervention
• Patient Sex: Unknown