MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-05 for QUANTUM QUANTUME SR GA3600000 manufactured by Lumenis, Inc..
[19940627]
The lumenis customer engineer ce found that the glass window in the customer power meter was dirty, causing possible energy variations. This foreign material contamination appears to be the root cause of the incident. Per the ce, the device output was within specification, but averaged high by 3-5%. The ce replaced the power meter glass window, performed an energy meter factor calibration and calibrated the treatment head. After preventive maintenance, the device passed safety and operational checks.
Patient Sequence No: 1, Text Type: N, H10
[20023806]
Per the customer, two pts had more intense reactions than expected to ipl photofacial treatment. Based on various reports from the customer, it appears that one pt had purpura and blistering following treatment at 22 joules and was prescribed silvadene cream. It appears that the second pt rec'd red stripes that had the potential to blister despite lowering the fluence from 27 to 25 joules (otc intervention only).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914019-2006-00114 |
| MDR Report Key | 806241 |
| Report Source | 00 |
| Date Received | 2007-01-05 |
| Date of Report | 2007-01-05 |
| Date of Event | 2006-12-07 |
| Date Mfgr Received | 2006-12-07 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2007-01-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANIS ARRIGONI |
| Manufacturer Street | 2400 CONDENSA STREET |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4087643208 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | YOKNEAM |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM |
| Generic Name | * |
| Product Code | MVF |
| Date Received | 2007-01-05 |
| Model Number | QUANTUME SR |
| Catalog Number | GA3600000 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793749 |
| Manufacturer | LUMENIS, INC. |
| Manufacturer Address | 13 HAYETZIRA STREET YOKNEAM IS |
| Baseline Brand Name | QUANTUM |
| Baseline Generic Name | * |
| Baseline Model No | QUANTUME SR |
| Baseline Catalog No | GA3600000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-05 |