FDA Adverse Event
Malfunction
Summary report: N
MAXI SKY 600
MDR report key: 1171338
·
Received September 17, 2008
Report
- Report Number
- 9681684-2008-00028
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 3, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN ARJO TECHNICIAN TESTED THE DEVICE, AND FOUND IT WORKING PER PRODUCT SPECIFICATIONS. THE USERS WERE AGAIN INSTRUCTED ON AUGUST 7TH, 2008 ON HOW TO USE THE LIFTER.
Description of Event or Problem · 1
THE FACILITY REPORTS THE CASSETTE WENT PARTIALLY OUT OF THE RAIL. THE CASSETTE WAS PUSHED BACK ONTO THE RAIL BY THE CARER. THE SAME DAY, THE INTERNAL MEDICAL SERVICE INFORMED ALL DEPARTMENTS ABOUT THE INFORMATION IN THE FIELD SAFETY NOTICE. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI SKY 600 | CEILING LIFT | FNG | BHM MEDICAL, INC. | LDXXXXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |