MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-11 for GIVEN IMAGING manufactured by Given Imaging.
[2430976]
Malfunction of ph monitoring device made by given imaging. After calibration of capsule and attachment within the esophagus the external receiver malfunctioned stating calibrate capsule. Capsule could not be recalibrated due to attachment within the esophagus. Capsule was removed. A different receiver a capsule were calibrated and the new capsule was attached without incident. No negative outcome with pt. The maker of the product, given imaging was notified. They were unable to assist with quality assurance diagnosis of the receiver since the product was out of warranty. Their only solution was to buy another receiver from them. They stated that they do not service products that are out of warranty in anyway. Dates of use: 2 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023806 |
| MDR Report Key | 2419187 |
| Date Received | 2012-01-11 |
| Date of Report | 2012-01-11 |
| Date of Event | 2011-12-21 |
| Date Added to Maude | 2012-01-19 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIVEN IMAGING |
| Generic Name | BRAVO PH RECEIVER |
| Product Code | NSI |
| Date Received | 2012-01-11 |
| Lot Number | 9043K0103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING |
| Manufacturer Address | 3950 SHACKLEFORD ROAD SUITE 500 DULUTH GA 30096 US 30096 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-11 |