FDA Adverse Event
Injury
Summary report: N
MAC VU360
MDR report key: 23646575
·
Received November 25, 2025
Report
- Report Number
- MW5179409
- Event Type
- Injury
- Date Received
- November 25, 2025
- Date of Event
- October 27, 2025
- Report Date
- November 17, 2025
- Manufacturer
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Product Code
- DPS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LVN- LICENSED VOCATIONAL NURSE NOTICED A FRAYED CORD THAT FELT WARM TO TOUCH. DEVICE WAS TAKEN OUT OF SERVICE NO INJURY TO STAFF OR PATIENT. EKG CART. GE HEALTHCARE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2137641 | MAC VU360 | ELECTROCARDIOGRAPH | DPS | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |