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

Model Number 18070

Device Problem No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 06/28/2016

Event Type  Injury  

Event 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 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 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
• Type of Device: 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
• MDR Text Key: 51814509
• Report Number: 2438477-2016-00036
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00822383264851
• UDI-Public: 00822383264851
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 12/11/2018
• Distributor Facility Aware Date: 07/07/2016
• Date Report to Manufacturer: 08/10/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 54 KG