MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for MEDLED MC3 CHROME manufactured by Riverpoint Medical.
[146344233]
According to the reporter, "at the year mark, customer plugged headlight into his charger and the charger caught fire, so he threw it away. Headlight is not charging anymore. " the customer reportedly discarded the charger and therefore riverpoint cannot confirm whether the charger was a riverpoint supplied medled charger. The customer was asked to provide additional details regarding the event. The customer stated that the event started with a puff of smoke and then the charger showed signs of overheating (some plastic was discolored) due to the fuse failing. No photos were available of the event. There was no injury as a result of the incident and no surrounding objects caught fire, according to the customer. Riverpoint performed a service investigation on the headlight that was returned. The investigation did not locate a failure that would have contributed to the incident described above. An investigation on the charger could not be performed as it was not returned. The ifu for the medled headlamp states "do not plug battery chargers into an extension cable" and "do not charge the batteries in the surgical field of use. " further details of the circumstances surrounding the incident were not provided by the customer. Trending analysis show that this is the first complaint for this headlight unit since release and the first complaint for a charging unit exhibiting failure. If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Patient Sequence No: 1, Text Type: N, H10
[146344234]
According to the reporter, "at the year mark, customer plugged headlight into his charger and the charger caught fire, so he threw it away. Headlight is not charging anymore. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006981798-2019-00006 |
| MDR Report Key | 8641943 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-26 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDWIN ANDERSON |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal | 97232 |
| Manufacturer Phone | 5035178001 |
| Manufacturer G1 | RIVERPOINT MEDICAL |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLED MC3 CHROME |
| Generic Name | SURGICAL HEADLAMP |
| Product Code | HPP |
| Date Received | 2019-05-24 |
| Model Number | MC3 |
| Lot Number | MC-160629-020421 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIVERPOINT MEDICAL |
| Manufacturer Address | 825 NE 25TH AVE. PORTLAND OR 97232 US 97232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |