FDA Adverse Event
Other
Summary report: N
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
MDR report key: 1062842
·
Received June 18, 2008
Report
- Report Number
- 2520313-2008-00011
- Event Type
- Other
- Date Received
- June 18, 2008
- Report Date
- June 18, 2008
- Manufacturer
- MEDRAD, INC.
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED PRODUCT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
HOSPITAL REPORTED WHEN THE TECHNICIAN WAS MOVING THE CONTINUUM ACROSS THE FLOOR, THE PUMP FELL FROM THE HOLDER AND HIT THE BACKSIDE OF THE PUMP ON THE FLOOR. THE BATTERY FROM THE PUMP LOOKS LIKE IT SHORTED AND CAUSED CHARRING OF THE PUMP CASING AND THE FLOOR. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM | INFUSION PUMP | FRN | MEDRAD, INC. | CONTINUUM MRIP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |