MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 2) OMRON COMPAIR COMPRESSOR NEBULIZER

Model Number NE-C801

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident.However, due to the customer stating that unit and ac adapter caused spark/fire, this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.

Event Description

The pharmacy representative called and informed that consumer returned the unit to pharmacy because ac adapter and unit caught fire.Omron consumer service representative advised pharmacy representative to not to replace any units for this reason and to have consumer contact omron directly.The caller did not know how long the unit was used for nor had proof of purchase.The caller also did not know how long the consumer had the unit for nor how long she had the ac adapter plugged in.The ac adapter was badly burned so cannot read if it is manufactured by omron or not.The caller did not have any additional information.During follow-up call on jan 2, 2020, the pharmacist stated unit was returned to pharmacy and what he knows is that the adapter threw out sparks but did not cause fire.The pharmacist was asked if he had consumer contact information so omron can speak to consumer directly.The pharmacist stated the unit was not returned directly to him and the person who got the unit back is not available at this time.Another follow-up call was made on jan 3, 2020 to obtain additional information.Unable to get in touch with contact at pharmacy.Omron representative spoke to pharmacist (who had taken the unit back from consumer) on jan 6, 2020.This pharmacist also did not have consumer contact information.The pharmacist was told that the adapter started on fire but that it.No additional information was provided.

Event Description

The pharmacy representative called and informed that consumer returned the unit to pharmacy because ac adapter and unit caught fire.Omron consumer service representative advised pharmacy representative to not to replace any units for this reason and to have consumer contact omron directly.The caller did not know how long the unit was used for nor had proof of purchase.The caller also did not know how long the consumer had the unit for nor how long she had the ac adapter plugged in.The ac adapter was badly burned so cannot read if it is manufactured by omron or not.The caller did not have any additional information.During follow-up call on jan 2, 2020, the pharmacist stated unit was returned to pharmacy and what he knows is that the adapter threw out sparks but did not cause fire.The pharmacist was asked if he had consumer contact information so omron can speak to consumer directly.The pharmacist stated the unit was not returned directly to him and the person who got the unit back is not available at this time.Another follow-up call was made on jan 3, 2020 to obtain additional information.Unable to get in touch with contact at pharmacy.Omron representative spoke to pharmacist (who had taken the unit back from consumer) on jan 6, 2020.This pharmacist also did not have consumer contact information.The pharmacist was told that the adapter started on fire but that it.No additional information was provided.

Manufacturer Narrative

Updated information concomitant medical products.A postage paid label was sent to retrieve the unit for further investigation and verbal request for unit return was made.A root cause was not determined when initial mdr was submitted.It was not confirmed if the device caused or contributed to the reported incident.However, due to the customer stating that unit and ac adapter caused spark/fire, this medwatch was filled.The u.S importer requested that the device manufacturer further investigate this incident.Unit was returned and investigated by the device manufacture.This follow-up mdr submitted to include investigation information.See below for updated information.The pharmacy returned the unit back for testing and was received by importer on 2/24/2020.During initial evaluation by importer on 02/28/2020, the unit passed the unit but ac adapter failed evaluation.Then the unit and the ac adapter was sent back to manufacturer for further detail investigation.Here is the summary of the manufacturer's device investigation: visual check found that the lower part of the terminal on one side of the ac adapter was deformed by heat.When the output characteristics of the ac adapter was confirmed by applying 240v/ 50hz with an ac stabilized power supply, it was within the standard range in the delivery specification.The applied voltage was set under the worst conditions for temperature with the rating of the ac adapter.There were no abnormalities in the basic performance characteristics of the returned main unit.The maximum temperature of the ac adapter was 40.6 c, when the combination of the returned main unit and the ac adapter was operated under the listed below conditions, and there was no abnormal heat generation near the terminal.[operating conditions]: applied voltage: 240v/ 50hz; which is the worst condition for temperature with the rating of this ac adapter.Operating time: until temperature is saturated.The main unit: the state that turned on the power supply with the neb kit attached.Since there were abnormalities in the appearance of the terminal on one side of the ac adapter and its surroundings found during visual inspection, it was judged that the issue was caused by an external cause due to following two points: there was no abnormality found in the basic performance of the returned main unit and the returned ac adapter.No abnormal heating occurred even when operated with the combination of the returned unit and returned ac adapter.Based on physical condition of the ac adapter terminal, the tracking phenomenon was considered as a probable cause.The instruction manual includes the following warning and caution respectively: do not connect the ac adapter terminal using wire or other metallic conductors.Unplug the ac adapter from the electrical outlet after using the device.The manufacturer reviewed the device history records, the qa test data and complaint history for similar issues.No issue/problem was noted during data reviewed.No issue or increasing trend was noted.Further investigation or an action is not required.

• Brand Name: OMRON COMPAIR COMPRESSOR NEBULIZER
• Type of Device: COMPRESSOR NEBULIZER
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 2); no. 28 dongbei er street, eco-; nomic & technical development; dalian liaoning, 11660 0; CH 116600
• MDR Report Key: 9566463
• MDR Text Key: 174256478
• Report Number: 1450057-2019-00003
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/08/2020,12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NE-C801
• Device Catalogue Number: NE-C801
• Device Lot Number: 20161103911UF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Distributor Facility Aware Date: 12/31/2019
• Device Age: 37 MO
• Event Location: Home
• Date Report to Manufacturer: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1