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 2020-01-16 for STERRAD? 100NX STERILIZER 1-DR 10104 manufactured by Advanced Sterilization Products.
[185494515]
A field service engineer was dispatched to the customer site. The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the smoke/haze issue. Unit meets specifications and was returned to service. Initial reporter phone #: (b)(6). Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185494516]
A customer reported an event of an odor or smell emitting from the sterrad? 100nx sterilizer. There was no report of any injuries or human reactions. 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 | 2084725-2020-00007 |
| MDR Report Key | 9597031 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-25 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-25 |
| Date Added to Maude | 2020-01-16 |
| 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 | 949503-026 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? 100NX STERILIZER 1-DR |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2020-01-16 |
| Catalog Number | 10104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-16 |