MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for GIVEN IMAGING PILLCAM RECORDER DR3 RFB-0347 manufactured by Given Imaging.
[111681709]
Given pillcam and recorder had two episodes where they stopped communicating. A reboot was performed following each failure with the first recording session lasting more than 3 hrs, and the subsequent session lasting more than 1. 5 hrs. This resulted in an incomplete/inconclusive test result. Diagnosis or reason for use: endoscopy - colonoscopy. "is the product compounded: no, is the product over-the-counter: no. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077920 |
| MDR Report Key | 7613408 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-06-14 |
| Date Added to Maude | 2018-06-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GIVEN IMAGING PILLCAM RECORDER DR3 |
| Generic Name | PILLCAM RECORDER & PILLCAM |
| Product Code | PGD |
| Date Received | 2018-06-18 |
| Model Number | DR3 |
| Catalog Number | RFB-0347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | GIVEN IMAGING GI PILLCAM |
| Generic Name | PILLCAM RECORDER & PILLCAM |
| Product Code | PGD |
| Date Received | 2018-06-18 |
| Lot Number | 39980X (PILLCAM) |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-18 |