MAUDE Adverse Event Report: EMG TECHNOLOGY CO. LTD. SCHUCO; NEBULIZER

Model Number S5000

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Visual evaluation as returned: no marks on unit indicating burning or overheating.Serial number on returned unit has been removed from label.The unit when returned for evaluation had the rubber feet, filter, tubing, instructions, and nebulizer cup missing.Label and manual: label on unit and instructions state: operation 20 minutes - off for 40 minutes.Instructions state: place compressor on a clean, dust free, stable and flat surface.We researched information on skin burns and it indicated burns can take place when surface temperature exceeds 109 degrees fahrenheit.We ran the unit for six (6) hours the highest temperature recorded was 102.5 degrees fahrenheit.Test results are on next page.(b)(4) standard list skin contact temperature should be below 109 degrees fahrenheit.The temperature test performed on the returned unit indicates this unit should not have burned the patient.Relevant tests/laboratory data, including dates: room temperature 72.5 degrees f.All readings in degrees fahrenheit.Test (b)(6) 2017.Time; top; front; right side; left side; back; bottom.20 minutes; 98.0; 85.0; 98.0; 77.0; 94.0; 94.0.1 hour; 99.5; 95.0; 93.5; 84.5; 97.5; 98.5.2 hours; 101.0; 94.5; 93.5; 88.0; 85.5; 102.5.3 hours; 99.0; 95.0; 93.5; 90.0; 97.5; 100.5.6 hours; 97.5; 93.5; 93.5; 89.0; 98.5; 98.5.

Event Description

Report states the patient was burned from the nebulizer.Further stated that she had two blisters, one on her left arm, and one on her left breast.

• Brand Name: SCHUCO
• Type of Device: NEBULIZER
• Manufacturer (Section D): EMG TECHNOLOGY CO. LTD.; taichung, ; TW
• MDR Report Key: 6742198
• MDR Text Key: 80989127
• Report Number: 1924066-2017-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: S5000
• Device Catalogue Number: S5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2017
• Event Location: Nursing Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other