MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-23 for PILLCAM M2A * manufactured by Given Imaging, Inc..
[382585]
A data from a capsule endoscopy recorder was not downloaded upon completion of the test. The recorder was not labeled as needing to be downloaded. The following day a new patient was set up with the data recorder and the data was lost on this previous patient. (data recorder download not verified before setting up next patient. ) procedure changed: first step will be to verify data recorder has been downloaded and saved prior to use. This event happened twice on the same day
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 608309 |
| MDR Report Key | 608309 |
| Date Received | 2005-05-23 |
| Date of Report | 2005-05-23 |
| Date of Event | 2005-05-11 |
| Report Date | 2005-05-23 |
| Date Reported to FDA | 2005-05-23 |
| Date Added to Maude | 2005-06-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | CAPSULE ENDOSCOPY IMAGING SYSTEM |
| Product Code | NSI |
| Date Received | 2005-05-23 |
| Model Number | M2A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 598105 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | OAKBROOK TECHNOLOGY CENTER 5555 OAKBROOK PARKWAY, 355 NORCROSS GA 30093 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-23 |