FDA Adverse Event
Summary report: N
LUCAS 2
MDR report key: 2173067
·
Received July 11, 2011
Report
- Report Number
- 2173067
- Date Received
- July 11, 2011
- Date of Event
- March 4, 2011
- Report Date
- July 11, 2011
- Manufacturer
- PHYSIO-CONTROL
- Product Code
- DRM
- Report Source
- User Facility report
- Reporter Location
- SD, US
Narratives
Description of Event or Problem · 1
LUCAS DEVICE IN USE DURING A CARDIAC ARREST OF AN ADULT PATIENT IN THE ED WHEN THE BATTERY FAILED. THE BATTERY WAS REPLACED WITH A FULLY CHARGED BATTERY WHICH ALSO FAILED. MANUAL COMPRESSIONS WERE CONTINUED BY STAFF. THE PATIENT EXPIRED.======================MANUFACTURER RESPONSE FOR CHEST COMPRESSEION SYSTEM, LUCAS 2, LUCAS 2 (PER SITE REPORTER)======================SEVERAL PHONE CALLS TO TECH SUPPORT WHO WOULD NOT VERIFY THAT THE PROBLEM RELATED TO THE ONGOING MEDICAL DEVICE CORRECTION WHICH THE DEVICE FALLS UNDER. THEY DON'T PROVIDE PARTS FOR THESE DEVICES. A LOANER MACHINE WAS RECEIVED OVER TWO WEEKS AFTER THE EVENT AT WHICH TIME OURS WAS SENT IN FOR REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUCAS 2 | COMPRESSOR, CARDIAC, EXTERNAL | DRM | PHYSIO-CONTROL | 100250-00 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | CARDIAC DRUGS |