MAUDE Adverse Event Report: WESTMED LLC MINI-HEART; HI-FLO CONTINUOUS NEBULIZER,ADLT AERO.MASK, 7

Model Number	100612A ;100612A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
4756-(appropriate term/code not available): nebulizer.The actual complaint product was not returned for evaluation.A review of the device history record is in progress.All information reasonably known as of 03 sep 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 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) 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
Fda user facility mw report mw (b)(4) reported, sometime in (b)(6) 2024, the miniheart hi-flo compressor nebulizer system(s) did not nebulize; the device was approximately 1 day old.There was no reported injury.
Additional Manufacturer Narrative
H6: 4756-(appropriate term/code not available): nebulizer additional information: d4; h6 correction: h10 the complaint investigation was performed based on the content of the issue reported.The device history record for lot 447757 was reviewed and the product was produced according to product specifications.The actual complaint product was not available for return, additionally, no photo images or video of the reported issue were provided; therefore, the complaint was unable to be confirmed, and no root cause was identified.All information reasonably known as of 06 nov 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 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
Fda user facility mw report (b)(4) reported, sometime in may 2024, the miniheart hi-flo compressor nebulizer system(s) did not nebulize; the device was approximately 1 day old.There was no reported injury.

• Brand Name: MINI-HEART
• Common Device Name: HI-FLO CONTINUOUS NEBULIZER,ADLT AERO.MASK, 7
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20131360
• Report Number: 2028807-2024-00030
• Device Sequence Number: 7221130
• Product Code: CAF
• UDI-Device Identifier: 00709078000232
• UDI-Public: (01)00709078000232(17)280918(10)447757
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K920443
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 100612A ;100612A
• Device Lot Number: 447757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/06/2024
• 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