MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-19 for TRIOS/STS CHEST PAD SUPPORT PLATE 5840-580 manufactured by Mizuho Orthopedic Systems, Inc..
[183883959]
Patient was transferred off of the table and the staff noticed the broken pad base. It was found the mizuho osi chest pad and support plate were being used on an allen spine frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2020-00008 |
| MDR Report Key | 9728878 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4291500233 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIOS/STS CHEST PAD SUPPORT PLATE |
| Generic Name | POSITIONER |
| Product Code | JEA |
| Date Received | 2020-02-19 |
| Model Number | 5840-580 |
| Catalog Number | 5840-580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |