MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for MON-A-THERM 90049 manufactured by Mmj Sa De Cv(usd).
[135000859]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[135000860]
According to the reporter, the unit failed to interface correctly with other device leading in a temperature cooler that the set patient's temperature. It was stated that they switch off the other device but the patient's temperature did not rise. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2019-00088 |
| MDR Report Key | 8300909 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2019-02-04 |
| 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 |
| 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 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,MX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MON-A-THERM |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2019-02-04 |
| Returned To Mfg | 2019-01-25 |
| Model Number | 90049 |
| Catalog Number | 90049 |
| Lot Number | 16F0730JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 DESARROL CIUDAD JUAREZ,MX 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |