MAUDE Adverse Event Report: SALTER LABS SALTER LABS; COMPRESSOR, NEBULIZER, (SALTER AIRE PLUS 220V) W/ NEBULIZER KIT NO. 8660

Model Number	8352-8660-7-1
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sparks coming from the back of the unit and smoking caused the compressor to stop working.Thus, it could have harmed the patient if the device was in use.
Event or Problem Description
While using the unit, sparks came out of the back and a puff of smoke.Unit stopped working.
Additional Manufacturer Narrative
Sparks coming from the back of the unit and smoking caused the compressor to stop working.Thus, it could have harmed the patient if the device was in use.No product or photo of the alleged defect was provided; therefore, the reported complaint could not be confirmed, and a root cause could not be determined.Most likely root cause is compressor damage caused by long-term use.A risk assessment was performed, and the ultimate risk was determined to be low, which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
While using the unit, sparks came out of the back and a puff of smoke.Unit stopped working.

• Brand Name: SALTER LABS
• Common Device Name: COMPRESSOR, NEBULIZER, (SALTER AIRE PLUS 220V) W/ NEBULIZER KIT NO. 8660
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18823039
• Report Number: 3000219639-2024-00027
• Device Sequence Number: 19964779
• Product Code: BTI
• UDI-Device Identifier: 00607411001536
• UDI-Public: 00607411001536
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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
• Device Model Number: 8352-8660-7-1
• Device Catalogue Number: 8352-8660-7-1
• Device Lot Number: KSN190501774
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown