MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD OPTION HOME COMPRESSOR; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1060509

Device Problem Fire (1245)

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

Event Date 10/31/2019

Event Type  malfunction  

Event Description

The manufacturer was made aware of an allegation an option home compressor was the cause of a thermal event in a home.There was no report of patient harm.No serial number was provided.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

A joint inspection was performed by a representative of the manufacturer and a representative of the claimant.The inspection confirmed the device was a philips device.The serial number could not be confirmed due to the exterior thermal damage sustained by the device.There was no evidence of thermal damage to the interior of the device.The manufacturer concludes that the thermal damage occurred as a result of an external event, and that the device did not cause or contribute to the reported event.

• Brand Name: OPTION HOME COMPRESSOR
• 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: adam price ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 11217494
• MDR Text Key: 257518373
• Report Number: 9681154-2021-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1060509
• Device Catalogue Number: 1060509
• Date Manufacturer Received: 03/12/2021
• 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: Unknown
• Patient Sequence Number: 1