MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-09-20 for SKYTRON 6500NB manufactured by Mizuho Medical Co., Ltd.
[717020]
Hospital claims skytron's 6500 surgical table went into trendelenburg and tilt left on it's own. Hospital now claims an injury to patients bowel.
Patient Sequence No: 1, Text Type: D, B5
[7876514]
Skytron was made aware of this incident in 2007, however, we were told by the hospital's bio-technician that there were no injuries. We contacted our distributor in the area, and associates to go to the hospital and examine the table. The hospital was advised by skytron to take the table out of service but they refused. They made the decision to use the table without repair regardless of the risk. Unk serial number at this time. We were informed on the following month, that there was an injury to a patient and are awaiting the information. The table has been repaired and continues to be in service. We will send a follow up as soon as the detail of the injury is known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2007-00013 |
| MDR Report Key | 921716 |
| Report Source | 08 |
| Date Received | 2007-09-20 |
| Date of Report | 2007-09-20 |
| Date of Event | 2007-08-28 |
| Date Facility Aware | 2007-08-28 |
| Report Date | 2007-09-20 |
| Date Reported to FDA | 2007-09-20 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2007-11-15 |
| 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 Street | 2-27-17 HONGO, BUNKYO-KU MRK BLDG. 5F |
| Manufacturer City | TOKYO 113-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 113-0033 |
| Manufacturer Phone | 1338181705 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2007-09-20 |
| Model Number | 6500NB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 909723 |
| Manufacturer | MIZUHO MEDICAL CO., LTD |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-20 |