MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-26 for STERRAD? NX STERILIZER 10033 manufactured by Advanced Sterilization Products.
[185490860]
A field service engineer was dispatched to the customer site. However, details of the resolution are pending and asp will continue to follow up for the service resolution. Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185490861]
A customer reported an event of smoke/haze and odor/smell emitting from the sterrad? Nx sterilizer. There was no report of any injuries or human reactions. The customer was advised to power down the unit, discontinue its use, and vacate the room. 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
[188891750]
A field service engineer was dispatched to the customer site and found no problem with the unit, no odor or haze was observed. He completed successful tests and confirmed that the unit met specifications. This file is no longer a reportable malfunction since no odor or haze could be confirmed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2019-01027 |
| MDR Report Key | 9521997 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-26 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2019-12-26 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0744-0746-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? NX STERILIZER |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2019-12-26 |
| Model Number | 10033 |
| Catalog Number | 10033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-26 |