MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. SALTER LABS; NEBULIZER, ADULT, OVER-THE-EAR STYLE AEROSOL MASK, 7' TUBE - 50/CS

Model Number	8904-7-50
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 3004748541-2025-00045 for the first report.Refer to 3004748541-2025-00047 for the third report.Refer to 3004748541-2025-00048 for the fourth report.Refer to 3004748541-2025-00049 for the fifth report.It was discovered during patient use, the mask did not fit properly, the nebulizer did not mist right and the oxygen (o2) tubing popped off.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 21 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.
Additional Manufacturer Narrative
Correction: d3; g1.Additional information-investigation completion: d4; h2; h6.The product involved in the report has not been returned for evaluation, additionally no photographic or videographic evidence was provided.In the absence of a photo or video, the complaint could not be confirmed.Without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 536954 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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
Sunmed holdings llc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 3004748541-2025-00045 for the first report.Refer to 3004748541-2025-00047 for the third report.Refer to 3004748541-2025-00048 for the fourth report.Refer to 3004748541-2025-00049 for the fifth report.It was discovered during patient use, the mask did not fit properly, the nebulizer did not mist right and the oxygen (o2) tubing popped off.There was no reported injury.
Additional Manufacturer Narrative
Correction: d9.Additional information_investigation complete: h2; h3; h6.A representative sample was returned and functional testing was performed.Test results revealed the mask was found to be within specifications.The reported issue, "mask does not fit properly" was not confirmed and the root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low.No corrective actions have been determined as a result of this investigation.All information reasonably known as of 01 apr 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 21 cfr 803, 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
Sunmed holdings llc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 3004748541-2025-00045 for the first report.Refer to 3004748541-2025-00047 for the third report.Refer to 3004748541-2025-00048 for the fourth report.Refer to 3004748541-2025-00049 for the fifth report.It was discovered during patient use, the mask did not fit properly, the nebulizer did not mist right and the oxygen (o2) tubing popped off.There was no reported injury.

• Brand Name: SALTER LABS
• Common Device Name: NEBULIZER, ADULT, OVER-THE-EAR STYLE AEROSOL MASK, 7' TUBE - 50/CS
• 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 TX 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 TX 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22866172
• Report Number: 3004748541-2025-00046
• Device Sequence Number: 18050352
• Product Code: CCQ
• UDI-Device Identifier: 00607411102028
• UDI-Public: (01)00607411102028(10)536954(17)300217(11)250217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K870027
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 8904-7-50
• Device Catalogue Number: 8904-7-50
• Device Lot Number: 536954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 03/02/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/26/2025; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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