MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-05 for HANA TABLE 6875 manufactured by Mizuho Orthopedic Systems, Inc..
[129316707]
Preventive maintenance was completed on 08/02/2018 and 11/14/2018 and the table passed the inspection. Conclusion of investigation is operator error of not having the patient safely strapped to the table and removing the perineal post prematurely before transferring patient. Two in-service were provided 11/15/2018 & 11/20/2018 to ensure that all staff members were in-serviced. The owner's manual includes instructions for securing the patient with a safety strap.
Patient Sequence No: 1, Text Type: N, H10
[129316708]
Patient fell off table - outcome unknown. As reported, the patient safety strap was not used. When preparing for patient transfer, the perineal post was pulled prematurely and the patient fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2018-00035 |
| MDR Report Key | 8132818 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2016-11-04 |
| Date Added to Maude | 2018-12-05 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANA TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | JEA |
| Date Received | 2018-12-05 |
| Model Number | 6875 |
| Catalog Number | 6875 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 945871234 US 945871234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-05 |