MAUDE Adverse Event Report: SHENZHEN HOMED MEDICAL DEVICE CO LTD DRIVE; NEBULIZER

Model Number	18070
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) received notification of an incident from a patient using a nebulizer that (b)(4) imports and distributes.The end user was using the nebulizer (18070) allegedly when the motor became increasingly louder and started vibrating.She powered the nebulizer on/off and no air flow was being produced.She was taken to (b)(6) hospital where she stayed for 2 days.The end user stated she is fine now but, would like a replacement unit.
Event or Problem Description
Drive medical received notification of an incident from a patient using a nebulizer that drive medical imports and distributes.The end user was using the nebulizer (18070) allegedly when the motor became increasingly louder and started vibrating.She powered the nebulizer on/off and no air flow was being produced.She was taken to hartford hospital where she stayed for 2 days.The end user stated she is fine now but, would like a replacement unit.Root cause and investigation update: the unit was returned under rma #60279426 and was evaluated by a member of the qe department.The evaluation report states that the root cause of this defect can be attributed to the fact that the eccentric gear on the motor was assembled too close to the connecting rod, creating friction and creating the black powder.Based on the investigation, the issue described in this complaint has already been addressed in scar 58 (which affected both 18070 &18080).The changes were implemented in (b)(6) 2015.The serial number of the unit in question (b)(6) predates these changes.
Event or Problem Description
Drive medical received notification of an incident from a patient using a nebulizer that drive medical imports and distributes.The end user was using the nebulizer (18070) allegedly when the motor became increasingly louder and started vibrating.She powered the nebulizer on/off and no air flow was being produced.She was taken to hartford hospital where she stayed for 2 days.The end user stated she is fine now but, would like a replacement unit.Root cause and investigation update: the unit was returned under rma #60279426 and was evaluated by a member of the qe department.The evaluation report states that the root cause of this defect can be attributed to the fact that the eccentric gear on the motor was assembled too close to the connecting rod, creating friction and creating the black powder.Based on the investigation, the issue described in this complaint has already been addressed in scar 58 (which affected both 18070 &18080).The changes were implemented in october 2015.The serial number of the unit in question (13s1507004734) predates these changes.

• Brand Name: DRIVE
• Common Device Name: NEBULIZER
• Manufacturer (Section D): SHENZHEN HOMED MEDICAL DEVICE CO LTD; 3rd floor, block1; huarong road, dalang street; shenzhen city, guangdong 51810 9; CH 518109
• MDR Report Key: 5866759
• Report Number: 2438477-2016-00036
• Device Sequence Number: 11092852
• Product Code: CAF
• UDI-Device Identifier: 00822383264851
• UDI-Public: 00822383264851
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018
• Report Date (Section F): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 18070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2016
• Date Report to Manufacturer: 08/10/2016
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 08/04/2023; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 12/11/2018