MAUDE Adverse Event Report: FOSHAN GAUNYING ELECTRONICS CO.,LTD BEURER; NEBULIZER(DIRECT PATIENT INTERFACE)

Model Number IH55

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2020

Event Type  malfunction  

Event Description

Nebulizer-model ih55 is intended to export to germany.A batch (batch number 2001002, quantity (b)(4)) sold to beurer(customer) was found to have a malfunction device during the customer's on-site inspection.The customer inspected the nebulizer-model ih55 and found that there was about 10s shutdown after was started.Quantity:(b)(4) date code: 2020f11 after engineering analysis, it was found that the cup shrapnel was in poor contact with the electrode column, resulting in poor induction with the medicine cup.In response to this problem, the engineering team developed short-term and long-term corrective&preventive actions.Short-term corrective actions: the manufacturer reworked the entire batch of device and conducted factory inspection again.After on-site inspection, the customer finds that the entire batch of products meets the requirements.Long-term corrective actions: subsequently, manufacturer conduct corrective actions, and also follow for the next three batches and no similar situation occurs.So this customer complaint was closed on july 30, 2020.In addition, no similar situation occurs from 2020 till today (2023-12-20), and no complaints have been received about this issue from 2020 till today (2023-12-20).

• Brand Name: BEURER
• Type of Device: NEBULIZER(DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FOSHAN GAUNYING ELECTRONICS CO.,LTD; no. 501, 5th floor, building 5; no. 51, jiang hai road, zhang; chan cheng district,foshan, guangdong 52800 0; CH 528000
• Manufacturer (Section G): FOSHAN GAUNYING ELECTRONICS CO., LTD; no.501,5th floor,building5,no.; 51jianghairoad,zhangcha street; chan cheng district, foshan, guangdong 52800 0; CH 528000
• Manufacturer Contact: ladi lee ; no. 501, 5th floor, building 5, no. 51,; jianghai road, zhangcha street,chan cheng district; foshan, guangdong 52800-0 ; CH 528000
• MDR Report Key: 18499667
• MDR Text Key: 333195217
• Report Number: 3008395118-2023-00001
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K14211NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IH55
• Device Lot Number: 2020F11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1