MAUDE Adverse Event Report: RIVERPOINT MEDICAL MEDLED; MEDLED ONYX / SAPPHIRE

Model Number ML-M-90002

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation at this time.The report has not been substantiated and a cause for the event has not been established.The investigation is ongoing.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.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, "it was reported batteries overheated and broke during use.Hospital states two batteries being used in sapphire headlight overheated, causing swelling that cracked housing of batteries while in use.Headlight was in use at time of event, and was quickly removed from use.".

• Brand Name: MEDLED
• Type of Device: MEDLED ONYX / SAPPHIRE
• 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 ; 5038178001
• MDR Report Key: 15499564
• MDR Text Key: 304983535
• Report Number: 3006981798-2022-00033
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML-M-90002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1