FDA Adverse Event
Death
Summary report: N
LUCAS 2
MDR report key: 17536103
·
Received August 12, 2023
Report
- Report Number
- MW5142993
- Event Type
- Death
- Date Received
- August 12, 2023
- Report Date
- October 18, 2021
- Manufacturer
- PHYSIO-CONTROL
- Product Code
- DRM
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE PATIENT WAS SENT TO OUR HOSPITAL DUE TO CARDIAC AND RESPIRATORY ARRES. THE PATIENT'S VITAL CHARACTERISTICS AT THE TIME OF THE EVENT: BODY TEMPERATURE 36.4, BREATHING BEATS/MIN, PULSE 0 BEATS/MIN, BLOOD PRESSURE 0/0MMHG, THE PERIPHERAL BLOOD OXYGEN SATURATION WAS 0%. WHEN THE MEDICAL STAFF USED THE CHEST COMPRESSION SYSTEM TO GIVE CPR TO THE PATIENT, THE CHEST COMPRESSION SYSTEM STOPPED WORKING AFTER 2 MINUTES OF USE. THE MEDICAL STAFF IMMEDIATELY PERFORMED CHEST HEART COMPRESSION MANUALLY, BUT THE RESCUE FAILED.) (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1074360 | LUCAS 2 | COMPRESSOR, CARDIAC, EXTERNAL | DRM | PHYSIO-CONTROL | LUCAS 2 {CHEST COMPRESSION DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |