MAUDE Adverse Event Report: RIVERPOINT MEDICAL MEDLED MC3 CHROME; SURGICAL HEADLAMP

Model Number MC3

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.".

• Brand Name: MEDLED MC3 CHROME
• Type of Device: SURGICAL HEADLAMP
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave.; portland, OR 97232 ; 5035178001
• MDR Report Key: 8641943
• MDR Text Key: 146344233
• Report Number: 3006981798-2019-00006
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MC3
• Device Lot Number: MC-160629-020421
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1