FDA Adverse Event
Malfunction
Summary report: N
FULL ELECTRIC FOOT SPRING 9153638201
MDR report key: 4989929
·
Received August 11, 2015
Report
- Report Number
- 1525712-2015-03952
- Event Type
- Malfunction
- Date Received
- August 11, 2015
- Report Date
- July 15, 2015
- Manufacturer
- UNKNOWN
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTAL ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
(B)(6) WAS SETTING UP A BED IN AN ASSISTED LIVING FACILITY AND SHE WAS SHOCKED WHEN SHE PLUGGED THE JUNCTION BOX INTO THE WALL OUTLET. SHE WAS NOT INJURED, JUST A TINGLE IN HER HAND. SHE DID NOT HAVE A MODEL OR SERIAL NUMBER TO PROVIDE. SHE SAID IT WAS A FULL ELECTRIC BED WITH AN INVACARE STICKER ON IT. SHE WAS NOT SURE IF THE WALL OUTLET WAS THE ISSUE OR NOT. THE BED DID NOT WORK AT ALL AFTER THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526031 | FULL ELECTRIC FOOT SPRING 9153638201 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |