MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED HOLDINGS LLC; EXCHANGER,HEAT/MOIST,SM,NO PORT

Model Number	DYNJAAHME12
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 06 mar 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 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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the patient's ventilator alarmed, the patient was removed from the vent and attempts were made to provide ventilation with an ambu-bag.Additionally, the heat and moisture exchanger (hme) was removed from the vent circuit and hooked to the expiratory filter outlet on the ambu-bag, the other end of the hme was hooked to the endotracheal tube (ett) and the expiratory port on the ambu-bag was left open; as a result, the patient did not receive the intended breaths.There was no reported injury.
Additional Manufacturer Narrative
Correction: g1.No physical sample, photo image, or video were provided by the reporter; therefore, the complaint was not confirmed.The supplier reviewed the device history record; no findings were noted during review.All information reasonably known as of 28 may 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, the patient's ventilator alarmed, the patient was removed from the vent and attempts were made to provide ventilation with an ambu-bag.Additionally, the heat and moisture exchanger (hme) was removed from the vent circuit and hooked to the expiratory filter outlet on the ambu-bag, the other end of the hme was hooked to the endotracheal tube (ett) and the expiratory port on the ambu-bag was left open; as a result, the patient did not receive the intended breaths.There was no reported injury.

• Brand Name: SUNMED HOLDINGS LLC
• Common Device Name: EXCHANGER,HEAT/MOIST,SM,NO PORT
• 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: 21542403
• Report Number: 1314417-2025-00011
• Device Sequence Number: 8334677
• Product Code: CAH
• UDI-Device Identifier: 10884389120453
• UDI-Public: (01)10884389120453(10)40020080063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: DYNJAAHME12
• Device Catalogue Number: DYNJAAHME12
• Device Lot Number: 40020080063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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