FDA Adverse Event
Malfunction
Summary report: N
SPIRIT ONE
MDR report key: 4879434
·
Received June 30, 2015
Report
- Report Number
- 3006433555-2015-00336
- Event Type
- Malfunction
- Date Received
- June 30, 2015
- Date of Event
- January 20, 2015
- Report Date
- January 20, 2015
- Manufacturer
- STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CHG HOSPITAL BEDS, INC. WAS ACQUIRED BY STRYKER ON JAN. 2, 2015. THIS MEDWATCH IS BEING SUBMITTED LATE BECAUSE IT WAS IDENTIFIED DURING THE INTEGRATION AND REMEDIATION ACTIVITIES INITIATED BY STRYKER MEDICAL IN CONJUNCTION WITH THIS ACQUISITION.
Description of Event or Problem · 1
IT WAS REPORTED THE FOOTEND LIFT DROPPED. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421889 | SPIRIT ONE | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |