MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for INVOS PATIENT MONITORING PMAC71DOC manufactured by Mmj Sa De Cv (usd).
[142626848]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142626849]
According to the reporter, during procedure, the device showed "signal error detected" and the rso2 values the lower or were not shown. It was indicated that there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2019-00289 |
| MDR Report Key | 8527663 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-10-30 |
| Date Added to Maude | 2019-04-18 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVOS PATIENT MONITORING |
| Product Code | QEM |
| Date Received | 2019-04-18 |
| Model Number | PMAC71DOC |
| Catalog Number | PMAC71DOC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV (USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-18 |