MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. SALTER LABS; NEBULIZER, NEBU TECH HDN, W/2 ONE-WAY VALVES, MOUTHPIECE

Model Number	8960-7
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.A review of the device history record is in-progress.All information reasonably known as of 31 oct 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 pop off valve had a loose fit and did not stay in place when in use during the nebulizer treatment.There was no reported injury.
Event or Problem Description
It was reported: the pop off valve had a loose fit and did not stay in place when in use during the nebulizer treatment.There was no reported injury.Additional information received 21oct2025 reported, the issue was discovered during setup of the nebulizer, immediately prior to placing the device on the patient.
Additional Manufacturer Narrative
Correction: b5.As there was no report of a delay in therapy or harm or injury to the patient and as the incident was discovered prior to patient contact, it has been determined that if this incident were to reoccur, as reported, it would not result in serious injury or harm and is therefore, not considered to be a reportable event.As the complaint was determined to be not reportable, no additional information will be submitted regarding the reported event.All information reasonably known as of 05 feb 2026 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: SALTER LABS
• Common Device Name: NEBULIZER, NEBU TECH HDN, W/2 ONE-WAY VALVES, MOUTHPIECE
• Manufacturer (Section D): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23440705
• Report Number: 3004748541-2025-00102
• Device Sequence Number: 17339199
• Product Code: CAF
• UDI-Device Identifier: 00607411890420
• UDI-Public: (01)00607411890420(10)NOP040918C
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K961476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 8960-7
• Device Catalogue Number: 8960-7
• Device Lot Number: NOP040918C
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/05/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown