MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-03-12 for 6850 PROFX DEVICE #1 manufactured by Mizuho Orthopedic Systems, Inc..
[1334108]
Customer stated that the table was not functioning and began smoking. Nurse pulled fire alarm.
Patient Sequence No: 1, Text Type: D, B5
[8446494]
The table did not burn; however, the controller and stepper motor overheated causing a burning smell. The smell caused the nurse to pull the fire alarm. The hospital's biomedical engineer (b)(6) stated that the nurse over reacted and should have just turned the table off and removed the table from the operating room. The table has been fixed and is currently in use at the hospital. The stepper motor controller and brake motor caused the smell and stopped working. After replacement of the brakes and motor controller and the table was fully operational. (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2010-00002 |
| MDR Report Key | 1637712 |
| Report Source | 06,07 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-03-08 |
| Date of Event | 2010-02-10 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2010-10-05 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | S.A.A. |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6850 PROFX DEVICE #1 |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2010-03-12 |
| Model Number | 6850 |
| Catalog Number | 6850 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-12 |