MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS PULMO-AIDE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	5650I
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive medical was notified of an incident involving a nebulizer compressor by the provider who reported that while in use, sparks came out from the damaged part of the power cord.The end user was not injured and did not seek medical attention.As part of its complaint review and evaluation process, drive medical will file an update if additional information becomes available.

• Brand Name: DEVILBISS PULMO-AIDE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 25634801
• Report Number: 2515872-2026-00017
• Device Sequence Number: 9561922
• Product Code: CAF
• UDI-Device Identifier: 00885304000907
• UDI-Public: (01)00885304000907
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K923888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: Lay User/Patient
• Device Model Number: 5650I
• 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: 06/01/2026
• Initial Report FDA Received Date: 06/26/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown