FDA Adverse Event
Malfunction
Summary report: N
MIDMARK
MDR report key: 4990313
·
Received August 1, 2015
Report
- Report Number
- 1523530-2015-00005
- Event Type
- Malfunction
- Date Received
- August 1, 2015
- Date of Event
- July 8, 2015
- Report Date
- July 31, 2015
- Manufacturer
- MIDMARK CORP.
- Product Code
- LGX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MIDMARK RECEIVED THE UNIT AND CONTINUES INVESTIGATION. NO ROOT CAUSE HAS YET BEEN DETERMINED. MIDMARK WILL PROVIDE FURTHER UPDATE UPON CONCLUSION OF INVESTIGATION OR VERIFICATION OF ROOT CAUSE.
Description of Event or Problem · 1
PATIENT WAS IN THE SEATED POSITION. THE MEDICAL ASSISTANT LOWERED THE BACK AND HEARD A NOISE. THE TOP END OF THE TABLE DROPPED TOWARD THE FLOOR. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502945 | MIDMARK | PROCEDURE TABLE | LGX | MIDMARK CORP. | 630-020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |