MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. ELEGANCE WITH SSD 120V60HZ US; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1100134

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/30/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation from a user of an elegance nebulizer that the prongs are missing in the power cord.There was no report of harm or injury.The manufacturer has requested the return of the device.The investigation is on-going.On completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the device for evaluation.The initial complaint of missing prongs on the ac power cord was confirmed.There was noted physical damage to the ac cord.There was no evidence of thermal damage, no exposed wires, no voids to the enclosure and no allegation of patient harm or injury.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: ELEGANCE WITH SSD 120V60HZ US
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer Contact: kimberly shelly ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 12990464
• MDR Text Key: 285937246
• Report Number: 9681154-2021-00023
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1100134
• Device Catalogue Number: 1100134
• Device Lot Number: 190730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2019
• 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