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

Catalog Number MS26372

Device Problem Unintended Electrical Shock (4018)

Patient Problem Numbness (2415)

Event Date 02/24/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

• Brand Name: INFINITY ACUTE CARE SYSTEM
• 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 ; 9784828529
• MDR Report Key: 18950389
• MDR Text Key: 338252086
• Report Number: 1220063-2024-00031
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: (01)04049098009751(11)200210(93)MS26372-53
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial

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 Catalogue Number: MS26372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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