MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for HANA TABLE 6875 manufactured by Mizuho Orthopedic Systems, Inc..
[66586764]
Patient Sequence No: 1, Text Type: N, H10
[66586825]
After intubation for surgery, the patient's right leg began to slip from hana table. Anesthesiologist and or staff present found it necessary to carefully lower patient to the floor. According to staff interviewed, the patient was heavy set ((b)(6) kgs) with weight mostly in the mid-section. Boots in hana bed was still not in place. Needed more than two staff to secure patient in hana bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6303585 |
| MDR Report Key | 6303585 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-12-08 |
| Report Date | 2016-12-20 |
| Date Reported to FDA | 2016-12-20 |
| Date Reported to Mfgr | 2016-12-20 |
| Date Added to Maude | 2017-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANA TABLE |
| Generic Name | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES |
| Product Code | JEB |
| Date Received | 2017-02-06 |
| Catalog Number | 6875 |
| Device Availability | Y |
| 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 AVE. UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |