MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for 3017 ETO STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[76627646]
A procedure delay was reported due to the event. A steris service technician arrived onsite to inspect the sterilizer and found the vacuum pump transducer required replacement. The vacuum pump transducer was not providing accurate readings of the pressure inside the chamber subsequently causing the "too long in evacuation" alarm. The technician replaced the vacuum pump transducer, tested the sterilizer and confirmed it to be operational.
Patient Sequence No: 1, Text Type: N, H10
[76627647]
The user facility reported their sterilizer alarmed for "too long in evacuation". No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005899764-2017-00025 |
| MDR Report Key | 6609261 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date of Event | 2017-05-03 |
| Date Mfgr Received | 2017-05-03 |
| Date Added to Maude | 2017-06-02 |
| 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. LYNDSEY SNYDER |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927386 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3017 ETO STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2017-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |