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 2020-03-10 for TRIOS/STS CHEST PAD SUPPORT PLATE 5840-580 manufactured by Mizuho Orthopedic Systems, Inc..
[183889467]
It was reported that the chest support assembly broke with a patient on the table. Patient was not injured. Break was at top of the side walls on both sides where it starts the attachment over the table rails. Velcro to secure to the tabletop was missing on both sides.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2020-00013 |
| MDR Report Key | 9811120 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-10 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-10 |
| 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 | SUPPORT PLATE |
| Product Code | JEA |
| Date Received | 2020-03-10 |
| Model Number | 5840-580 |
| Catalog Number | 5840-580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-10 |