FDA Adverse Event
Summary report: N
KINAIRE MED SURG
MDR report key: 1251563
·
Received November 19, 2008
Report
- Report Number
- 1251563
- Date Received
- November 19, 2008
- Date of Event
- September 30, 2008
- Report Date
- November 19, 2008
- Manufacturer
- KINETIC CONCEPTS, INC.
- Product Code
- INX
- Report Source
- User Facility report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PATIENT (STATUS/POST MULTIPLE FIXATION SURGERIES) WAS FOUND ON THE FLOOR KNEELING AGAINST THE KINAIRE BED. THE PATIENT REPORTED SHE/HE HAD BEEN REACHING FOR THE BEDPAN ON A LEDGE AND SLOWLY SLID OUT OF THE BED AS THE AIR IN THE MATTRESS SHIFTED. (THE MIDDLE SECTION OF THE BED WAS LOWER THAN THE HEAD/FOOT OF BED). PATIENT WAS ASSISTED BACK INTO THE BED. PATIENT COMPLAINED ABOUT SORENESS IN HIS/HER RIGHT SHOULDER AND CALF. NO REDNESS/ABRASIONS NOTED. X-RAYS WERE TAKEN OF ANKLE, TIBIA AND RIGHT SHOULDER AND ALL X-RAYS SHOWED NO CHANGE FROM PREVIOUS FILMS. THE NEXT A.M., THE KINAIRE BED WAS DISCONTINUED AND A REGULAR BED WITH AN AIR MATTRESS TOPPER WAS ORDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINAIRE MED SURG | BED, LOW AIR LOSS | INX | KINETIC CONCEPTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |