MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUN MED; EDITH 1000 HME, DISPOSABLE

Model Number	557055200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 24 jun 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, there was a crack in the connector while it was in use on the patient.There was no reported injury.
Event or Problem Description
It was reported, there was a crack in the connector while it was in use on the patient.There was no reported injury.
Additional Manufacturer Narrative
Additional information-investigation conclusions: h6.The product involved in the report was not returned for evaluation; without a sample to perform functional evaluation, a root cause could not be determined.However, the reporter provided photographic evidence, which was used to confirm the event as reported.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 14 aug 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: SUN MED
• Common Device Name: EDITH 1000 HME, DISPOSABLE
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22321862
• Report Number: 1314417-2025-00040
• Device Sequence Number: 9023736
• Product Code: BYD
• UDI-Device Identifier: 10190752139800
• UDI-Public: (01)10190752139800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 557055200
• Device Catalogue Number: 557055200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown