MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for OHMEGA manufactured by Medical Measurement Systems B.v..
[141479128]
Patient sent home with ohmega ph catheter and recorder. Patient had called in the evening, stating the device was not showing the time, but stating still registering "record". Instructed to utilize as directed. Upon return the next day, when recorder downloaded to mms, information was not able to be downloaded. Error message was memory failure. Mms manufacturer was called. We are still waiting to hear from the manufacturer as to whether the information can be retrieved or the study will need to be repeated for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499612 |
| MDR Report Key | 8499612 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-22 |
| Report Date | 2019-02-27 |
| Date Reported to FDA | 2019-02-27 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEGA |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2019-04-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL MEASUREMENT SYSTEMS B.V. |
| Manufacturer Address | UNISENSOR (USA) INC. 112 CORPORATE DR STE 12 PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-10 |