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 2012-11-05 for MULTISCAN TABLE 8083 manufactured by Medical Positioning, Inc..
[22039431]
The bed was in it's lowest height and in a horizontal position. As the technician began to raise the height of the bed, the head portion of the bed tilted down due to the trendelenburg actuator clevis breaking and releasing. As a result, the patient slid toward the head of the bed forcing his legs upward but did not fall off the bed. The patient suffers with back pain which seem to be aggravated by the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932056-2012-00006 |
| MDR Report Key | 2835359 |
| Report Source | 04,05,06 |
| Date Received | 2012-11-05 |
| Date of Report | 2012-11-05 |
| Date of Event | 2012-10-25 |
| Date Mfgr Received | 2012-10-25 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2012-12-07 |
| 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 | JOE HURTIG, MGR. |
| Manufacturer Street | 1717 WASHINGTON ST. |
| Manufacturer City | KANSAS CITY MO 64108 |
| Manufacturer Country | US |
| Manufacturer Postal | 64108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISCAN TABLE |
| Generic Name | MULTISCAN TABLE |
| Product Code | LGX |
| Date Received | 2012-11-05 |
| Model Number | 8083 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL POSITIONING, INC. |
| Manufacturer Address | 1717 WASHINGTON ST. KANSAS CITY MO 64108 US 64108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-05 |