MAUDE Adverse Event Report: NARKOMED GS ANESTHESIA MACHINCE; GAS-MACHINE, ANESTHESIA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 04/04/2012

Event Type  Injury  

Event Description

It was reported that while trying to reposition the anesthesia machine in operating room#9 (b)(6) (or staff) was shocked in her right ankle causing paresthesia to her rt lateral foot and two most lateral toes.No burn mark was noticed and paresthesia has since resolved.While helping to reposition the machine again the anesthesia technician, (b)(6), was also shocked in her left hand with no resulting issues.The or was closed, the anesthesia machine removed and biomedical engineering notified.Further details: hospital biomed, david lowe, reported that after inspecting equipment they could not find any hazards and all equipment passed safety inspections.Facilities also checked the room and found no problems.The lim (line isolation monitor) was never tripped.As a precautionary measure, a stryker field service technician was dispatched the account on 4/11/12 to inspect the stryker equipment that was connected to the anesthesia machine.The technician powered on all equipment and could not recreate the issue.He checked for cables that are shorted out around the boom and no issues were found.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: GS ANESTHESIA MACHINCE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): NARKOMED
• MDR Report Key: 17516447
• MDR Text Key: 321048793
• Report Number: MW5123396
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2012

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2023
• Patient Sequence Number: 1