MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-29 for 8900 DRYVIEW LASER 1780774 manufactured by Carestream Health, Inc..
[4916814]
Customer reported a burning odor coming from the unit.
Patient Sequence No: 1, Text Type: D, B5
[12264530]
The device was returned to carestream. A root cause investigation is currently in progress. A follow up report will be submitted. A follow up report will be submitted. The site at which the unit was manufactured is now closed and this product is no longer manufactured.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134259-2014-00016 |
| MDR Report Key | 4156087 |
| Report Source | 05 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-09-12 |
| Date Mfgr Received | 2014-09-12 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2014-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 150 VERONA ST |
| Manufacturer City | ROCHESTER NY 14608 |
| Manufacturer Country | US |
| Manufacturer Postal | 14608 |
| Manufacturer Phone | 5856278230 |
| Manufacturer G1 | OAKDALE (COLUMBIA PLANT) |
| Manufacturer Street | 1 IMATION WAY |
| Manufacturer City | OAKDALE MN 55128 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8900 DRYVIEW LASER |
| Generic Name | 8900 DRYVIEW LASER IMAGER |
| Product Code | LMC |
| Date Received | 2014-09-29 |
| Returned To Mfg | 2014-09-14 |
| Model Number | 8900 |
| Catalog Number | 1780774 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC. |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-29 |