MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-12 for STERRAD? 100S STERILIZER 10101 manufactured by Advanced Sterilization Products.
[182558287]
A field service engineer was dispatched to the customer site. The catalytic converter was replaced to resolve the smoke/haze issue. Unit meets specifications and was returned to service. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182558288]
A customer reported an event of a "steam" or a smoke/haze emitting from the sterrad? 100s sterilizer. There was no report of any injuries or human reactions. It is unclear whether or not there was a cycle cancellation with this event and asp will continue to follow-up for further information. An asp field service engineer was dispatched to assess the unit onsite. This event is being reported as a malfunction report subsequent to a serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-01005 |
| MDR Report Key | 9461201 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-12 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 1998-11-23 |
| Date Added to Maude | 2019-12-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949453-639 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? 100S STERILIZER |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2019-12-12 |
| Model Number | 10101 |
| Catalog Number | 10101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-12 |