MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for PILLCAM RECORDER DR3 FGS-0347 manufactured by Given Imaging, Inc..
[177818615]
Inpatient in ticu was scheduled for capsule endoscopy. Protocol followed to prepare and pair capsule and recorder without any difficulties. Nurse had patient swallow capsule. Within 10 minutes, recorder flashing yellow light every 5 seconds indicating that the recorder was not receiving signals from the capsule. Nurse called medtronic tech support to troubleshoot problem. After attempts to correct issue, the recorder did continue with the flashing yellow light every 5 seconds. When the recorder was downloaded, the study showed the capsule signals were not detected by the recorder. The study was incomplete. The conclusion was that the patient was on telemetry which can cause interference with the capsule study. Using different equipment, the capsule study was repeated with the patient off telemetry (patient remained in ticu). There were episodes where the yellow light would flash every 5 seconds. The study did show that there was interference and that the capsule signal was not received by the recorder. This study was also incomplete. Pillcam recorder ref: fgs-0347 and capsule. Capsule ids: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9671047 |
| MDR Report Key | 9671047 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-07 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | RISK MANAGER |
| 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 | PILLCAM RECORDER DR3 |
| Generic Name | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
| Product Code | NEZ |
| Date Received | 2020-02-05 |
| Catalog Number | FGS-0347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |