FDA Adverse Event
Malfunction
Summary report: N
LIKORALL 250 ES, NATURAL
MDR report key: 4321698
·
Received November 24, 2014
Report
- Report Number
- 8030916-2014-00109
- Event Type
- Malfunction
- Date Received
- November 24, 2014
- Date of Event
- November 4, 2014
- Report Date
- November 4, 2014
- Manufacturer
- LIKO AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING INVESTIGATION, IT HAS BEEN NOTED THAT THE SWITCH DRIVER (CIRCUIT IC21 ON THE PCBA WAS HOT. THIS CIRCUIT IS INVOLVED WHEN CONTROLLING THE TRAVERSE SWITCH AND CHARGING THE LIFT MOTOR THROUGH THE MULTI STATION CHARGER. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFTS. THE TECH REPLACED THE ELECTRONIC CARD SWITCH COVER 243/250 ES TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECH STATING A MULTI-CONNECTOR/MULTI STATION CONTACT WAS ARCING. THE LIFT WAS LOCATED IN CRITICAL CARE UNIT (CCU). THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761786 | LIKORALL 250 ES, NATURAL | NON-AC POWERED PATIENT LIFT | FSA | LIKO AB | P3122501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |