MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-16 for CHICK CLT ORTHOPAEDIC TABLE 10500 manufactured by Midmark Corp..
[8541]
Pt was on orthopaedic table when it malfunctioned: pt would have fallen if personnel present had not been able to restrain him. Table was in reverse trendelenburg position with 5-10 degrees left tilt. When lateral tilt was turned, the table did not respond, and pt went full tilt, 15 degrees. Personnel on left side of table were able to keep him from falling and returned table to level. Pt had stated weight as 300 lbs when admitted with broken femur, table limit is 350 lbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001120 |
| MDR Report Key | 12076 |
| Date Received | 1994-03-16 |
| Date of Report | 1994-02-28 |
| Date of Event | 1994-02-13 |
| Date Added to Maude | 1994-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHICK CLT ORTHOPAEDIC TABLE |
| Generic Name | ORTHOPAEDIC TILT TABLE |
| Product Code | JFB |
| Date Received | 1994-03-16 |
| Model Number | 10500 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12076 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH 453809310 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-16 |