MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for ZEPHR Z07-2000-B manufactured by Sandhill Scientific, Inc..
[100768926]
Patient Sequence No: 1, Text Type: N, H10
[100768927]
The study equipment was placed on patient and the study was started. When it was time for the study to end, the ph machine had a blank, lit blue screen and was unresponsive. Batteries were removed to turn off machine. The batteries were switched, the machine was turned back on, and machine was functional but had no record of ph/mcr study. There was no record of the study on the sd card either. The study data was lost and the test had to be repeated. Manufacturer response for ph monitoring device, zephyr ph monitoring system (per site reporter): exchanged part that was unrepairable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7291704 |
| MDR Report Key | 7291704 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-10-29 |
| Report Date | 2018-01-29 |
| Date Reported to FDA | 2018-01-29 |
| Date Reported to Mfgr | 2018-01-29 |
| Date Added to Maude | 2018-02-23 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | ZEPHR |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-02-23 |
| Model Number | Z07-2000-B |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANDHILL SCIENTIFIC, INC. |
| Manufacturer Address | 9150 COMMERCE CENTER CIR STE 500 HIGHLANDS RANCH CO 80129 US 80129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-02-23 |