MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-07 for SKYTRON 3600B manufactured by Mizuho Medical Co., Ltd.
[673923]
A patient, had an open heart surgery procedure with patient reversed on the table. Patient's chest began to fill with fluid, so the anesthesiologist put table in reverse trendelenburg position. According to the staff, the table began to tip towards anesthesia. While attempting to prevent the patient from falling, two male staff members leaned on table and grabbed patient. The patient was not restrained while on the table and nobody saw the feet of the table actually lift off the floor. The incident occurred at: the medical center.
Patient Sequence No: 1, Text Type: D, B5
[7811634]
Skytron sent the local distributor to the facility to assess the situation. He received conflicting information from the medical staff in the or. We will continue to monitor the situation and send the fda updates as we receive them.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2007-00010 |
| MDR Report Key | 893447 |
| Report Source | 08 |
| Date Received | 2007-08-07 |
| Date of Report | 2007-08-06 |
| Date of Event | 2007-07-31 |
| Date Facility Aware | 2007-07-31 |
| Report Date | 2007-08-06 |
| Date Reported to FDA | 2007-08-06 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2007-09-11 |
| 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 | MRK BLDG. 5F 2-27-17 HONGO, BUNKYO-KU |
| Manufacturer City | TOKYO 113-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 113-0033 |
| Manufacturer Phone | 1338181705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2007-08-07 |
| Model Number | 3600B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 883480 |
| Manufacturer | MIZUHO MEDICAL CO., LTD |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-08-07 |