MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422500
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Headache (1880)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that a rt got shocked.Customer is alleging a device malfunction in this incident.After the electric shock, the nurse pain from her right fingers, up her arm, and through her head and neck.She was sent home from that shift.
Event or Problem Description
It was reported that a rt got shocked.Customer is alleging a device malfunction in this incident.After the electric shock, the nurse pain from her right fingers, up her arm, and through her head and neck.She was sent home from that shift.
Additional Manufacturer Narrative
After the electric shok, the nurse pain from her right fingers, up her arm, and through her head and neck.The complaint investigation of provided information and onsite investigation identified no technical malfunction of evita v800 with serial no.(b)(6) that could have caused the electric shock.Electrical safety of the ventilator was successfully checked by dräger service in accordance with the standard iec 60601-1 (3rd edition).The incident may have been caused by a power strip belonging to the operator into which the ventilator was plugged in.As per the service report, the affected ventilator evita v800 (b)(6) successfully passed all functional tests and electrical safety tests carried out by draeger service in accordance with the manufacturer's test protocol.No technical malfunction of the ventilator was identified that could have caused the electric shock.It was observed by draeger service that the ventilator was connector to a power strip which was not physically examined and may have been the cause of the reported incident.Evita v800 complies with the standard iec 60601-1 (3rd edition) and its requirements for basic safety and essential performance.This includes the freedom from unacceptable risk directly caused by physical hazards, such as electric shock.Electrical safety of evita v800 must be checked every 12 months as outlined in the corresponding ifu.To date, dräger did not yet receive other complaints from the field regarding similar cases of electrical shock under involvement of evita v600/v800 and babylog vn600/vn800.The complaint did not reveal any new or additional risk as already considered by the device risk management file.

• Brand Name: EVITA V800
• Common Device Name: ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24661664
• Report Number: 9611500-2026-00118
• Device Sequence Number: 13068115
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)250513(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PR169803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: Other
• Patient Sex: Unknown