MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2012-12-26 for ECHOBED 1222 manufactured by Medical Positioning, Inc..
[19193352]
The customer owns an echobed model 1222 which was ten (10) yrs old, which is three (3) rs outside of it's seven (7) yr design life. The product utilizes a central braking (single pedal) system to lock the products casters (wheels). As the pt was leaning against the side of the table to get on it for the procedure, the brakes came unlocked and the bed rolled away from the pt. The pt temporarily lost his balance and his back made contact with the safety rail bracket causing a small contusion. In this case, the pt was able to regain his balance before falling all the way to the ground.
Patient Sequence No: 1, Text Type: D, B5
[19410440]
It was determined that the inadvertent unlocking of the casters was due to the fact that the product was in use at the customer facility for three yrs longer than its expected design life. The extended use of the product caused excessive ware on the mechanical locking mechanism allowing it to become easily unlocked. Medical positioning, inc. Has determined in its risk file for this product that inadvertent brake release may result in a pt fall which could cause a brake. The risk mitigation for this potentially hazardous situation is to include a check of the caster locks as part of the annual preventive maintenance schedule noted in the owner's manual of medical positioning, inc. Products. Had the preventive maintenance schedule been completed at the user facility this hazardous situation could have been avoided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932056-2012-00007 |
| MDR Report Key | 2896534 |
| Report Source | 04,05,06 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-17 |
| Date of Event | 2012-12-13 |
| Date Mfgr Received | 2012-12-13 |
| Device Manufacturer Date | 2003-10-29 |
| Date Added to Maude | 2013-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSEPH HURTIG, QUALITY MGR, MANA |
| Manufacturer Street | 1717 WASHINGTON STREET |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Manufacturer Phone | 8165952356 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHOBED |
| Generic Name | ECHOBED |
| Product Code | LGX |
| Date Received | 2012-12-26 |
| Model Number | 1222 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-26 |