MAUDE Adverse Event Report: SALTER LABS SALTER LAB; COMPRESSOR, NEBULIZER, (SALTER AIRE PLUS 230V) W/ NEBULIZER KIT NO. 8924

Model Number 8353-8924-7-1

Device Problem Material Integrity Problem (2978)

Patient Problem Electric Shock (2554)

Event Date 05/23/2023

Event Type  Injury  

Event Description

Patient reported to nursing staff that they sustained an electric shock from a portable nebuliser machine.On examination, the nebuliser port was found to have been pushed inside the device whereby it was possible to see electrical wiring.This compressor is a double insulation device and is still operable.Whilst it is possible to see some electrical wiring i was unable to determine how the patient managed to receive an electric shock.

Manufacturer Narrative

The patient receiving and electoral shock due to port being pushed in is a health hazard.Even though the clinician was unable to determine where patient may have received electrical shock, if there are any abnormalities with unit it should not be used.

Manufacturer Narrative

The patient receiving and electoral shock due to port being pushed in is a health hazard.Even though the clinician was unable to determine where patient may have received electrical shock, if there are any abnormalities with unit it should not be used.Complaint history reviewed: 0 similar complaints for product group under "exposed wire", 0 similar complaints for product group under "power cord issue", 5 under "broken/cracked", upon review - 1 similar complaint for this issue.Issue does not appear to be trending.Pictures show case of compressor has been split and the outlet plug has been pushed into the unit.Customer stated end user sustained shock from unit, however was unable to recreate shock.Without returned unit, further investigation into shock hazard cannot be completed.Risk(rma-20013c): r70: electrical wires exposed to user - power cord insulation damaged - s=7 o=2 rpn=14.Rpn<25, therefore risk is acceptable.

Event Description

Patient reported to nursing staff that they sustained an electric shock from a portable nebuliser machine.On examination, the nebuliser port was found to have been pushed inside the device whereby it was possible to see electrical wiring.This compressor is a double insulation device and is still operable.Whilst it is possible to see some electrical wiring i was unable to determine how the patient managed to receive an electric shock.

• Brand Name: SALTER LAB
• Type of Device: COMPRESSOR, NEBULIZER, (SALTER AIRE PLUS 230V) W/ NEBULIZER KIT NO. 8924
• 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: 17081768
• MDR Text Key: 316844089
• Report Number: 3000219639-2023-00018
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8353-8924-7-1
• Device Catalogue Number: 8353-8924-7-1
• Device Lot Number: 1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other