MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-09-25 for STERRAD 200 STERILIZATION SYSTEM 10201-001 NA manufactured by Yamato Lab-tech Co., Ltd.
[698328]
The customer reported a haze coming from their unit. The customer stated that there were no reports of physicial symptoms related to the oil mist. The asp field svc engineer went to the facility to repair the unit.
Patient Sequence No: 1, Text Type: D, B5
[7881333]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2007-00270 |
| MDR Report Key | 918242 |
| Report Source | 05 |
| Date Received | 2007-09-25 |
| Date of Report | 2007-08-28 |
| Date of Event | 2007-08-28 |
| Date Mfgr Received | 2007-08-28 |
| Date Added to Maude | 2007-11-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE PRIOLO |
| Manufacturer Street | 33 TECHNOLOGY DR. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893857 |
| Manufacturer G1 | YAMATO LAB-TECH CO, LTD |
| Manufacturer Street | 322 TODA MINAMI-ALPA-CITY |
| Manufacturer City | YAMANASHI 400-0414 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 400-0414 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1630-2008 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD 200 STERILIZATION SYSTEM |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2007-09-25 |
| Model Number | 10201-001 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 902129 |
| Manufacturer | YAMATO LAB-TECH CO., LTD |
| Manufacturer Address | YAMANASHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-25 |