MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for 16" CENTURY STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[184922042]
A steris service technician arrived onsite to inspect the 16" century sterilizer. While onsite, the user facility provided the technician with their cycle tapes. The technician reviewed the tapes and did not identify a cycle tape that aligned with the alarm subject of the reported event. The unit will alarm if the chamber does not reach the set temperature within the allotted time. The alarm indicates that the facility's steam supply is not providing sufficient steam to reach the set temperature. Additionally, the technicians spoke with the user facility's biomed department who stated that after reported event they had to "reset" the unit and returned the sterilizer to service. The technician performed an inspection and found no issue with the function or operation of the sterilizer. No repairs were required. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[184922043]
The user facility reported via user facility medwatch report number (b)(4) that their 16" century sterilizer did not reach the proper temperature to continue the cycle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005899764-2020-00009 |
| MDR Report Key | 9787986 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 16" CENTURY STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLE |
| Date Received | 2020-03-04 |
| 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, 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |