MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-27 for SECHRIST 3500 HL LOW-FLOW AIR OXYGEN BLENDER MIXER FOSC3000 manufactured by Sechrist Industries, Inc.
[181554661]
The complaint device was returned for evaluation. Initial visual inspection found no anomalies. Device evaluation identified that a knob was loose. The unit was re-calibrated. The alarm calibration test was ran and tested to oem specification. The root cause for the measurements being off was determined to be a loose know; however, it is unknown how the knob became loose. It was determined that this was not related to the previous repair. This type of event will continue to be monitored.
Patient Sequence No: 1, Text Type: N, H10
[181554662]
Reportedly, post repair, the device was reading off by 6%. There was no report of patient harm. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00041 |
| MDR Report Key | 9765291 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-27 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4495328128 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECHRIST 3500 HL LOW-FLOW AIR OXYGEN BLENDER MIXER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-14 |
| Model Number | FOSC3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC |
| Manufacturer Address | 4225 EAST LA PALMA ANAHEIM, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |