FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 HOTLINE IV FLUID WARMER
MDR report key: 3170384
·
Received May 24, 2013
Report
- Report Number
- 2183502-2013-00241
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LGZ
- PMA / PMN Number
- K911383
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
A USER FACILITY REPORT WAS RECEIVED THAT STATED THAT WHILE SWITCHING THE DEVICE ON, THE NURSE RECEIVED AND ELECTRIC SHOCK. NO INJURY WAS REPORTED. THE DEVICE WAS REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231678 | LEVEL 1 HOTLINE IV FLUID WARMER | LGZ - WARMER, THERMAL, INFUSION FLUID | LGZ | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |