MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED; GREENLINE SUNBRITE LED PENLITE HANDLE

Model Number	5-0236-90, 5-0236-99
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 11 sept 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
Light flickers.We have been having problems with flickering in our greenline sunbrite led handles (5-0236-99 and 5-0236-90).Have you had any other complaints? one of the doctors said if he loosens the bulb it doesn't flicker.It's like there is too much distance between the battery and the bulb.Typical use,.
Additional Manufacturer Narrative
All information reasonably known as of 11 sept 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.Per wi-20020-c1 rev 2, sec 15.6: for products in which airlife distributes, but is not the manufacturer, complaints will be captured and disseminated to the manufacturer but does not require investigation, reportability assessment, capa escalation, risk analysis, as this is the responsibility of the legal manufacturer and will be closed.
Event or Problem Description
Light flickers.We have been having problems with flickering in our greenline sunbrite led handles (5-0236-99 and 5-0236-90).Have you had any other complaints? one of the doctors said if he loosens the bulb it doesn't flicker.It's like there is too much distance between the battery and the bulb.Typical use,.

• Brand Name: SUNMED
• Common Device Name: GREENLINE SUNBRITE LED PENLITE HANDLE
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, china 51917 0; CH 519170
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20195814
• Report Number: 1314417-2024-00027
• Device Sequence Number: 7583999
• Product Code: CCW
• UDI-Device Identifier: 10889483008881
• UDI-Public: (01)10889483008881
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5-0236-90, 5-0236-99
• Device Catalogue Number: 5-0236-90, 5-0236-99
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown