MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-10-08 for CHROMOPHARE 660 manufactured by Berchtold.
[4785330]
It was reported that during a ureteral pyeloureterostomy surgical procedure, a patient (baby), was allegedly burned while two lights were focused on the surgical site. The patient was referred to dermatology and it was determined that the patient received a 2nd degree burn. The patient was treated with silvadene 1 percent cream and was advised to continue that treatment twice daily.
Patient Sequence No: 1, Text Type: D, B5
[12317995]
It was reported that during a ureteral pyeloureterostomy surgical procedure, a patient (baby), was burned while two lights were focused on the surgical site. Through investigation between the customer and berchtold service technician, it was determined that both lights were focused on the surgical site, the intensity was at it's highest, the light spot was about 6 inches and the health care professionals did not review the user manual. The user manual provided to the customer warns "the overlay of the light fields can cause an increase in heat generation". The root cause was determined to be user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220865-2014-00005 |
| MDR Report Key | 4162845 |
| Report Source | 05,07 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-09-16 |
| Date Mfgr Received | 2014-09-16 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2014-10-14 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS MANNARINO |
| Manufacturer Street | 1950 HANNAHAN ROAD |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8435696100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMOPHARE |
| Generic Name | CEILING MOUNTED SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2014-10-08 |
| Model Number | 660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD |
| Manufacturer Address | CHARLESTON SC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-08 |