MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD OPTIONHOME COMPRESSOR; COMPRESSOR, AIR PORTABLE

Model Number 1060509

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Asthma (1726); Bronchitis (1752)

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device still in use.Not returned.

Event Description

Philips internal reference (b)(4).A caregiver reported that his son required two emergency room (er) visits for breathing treatments within the same week, and was treated and released each time due to asthma and bronchitis.A physician alerted the caregiver during the second visit that the filter on their optionhome compressor was very dirty, and that his son was inhaling dust from the filter.The caregiver reported the filter had not been changed for four years.From the latest available information the filter has been replaced, the patient is still using the device, and is recovering.The device was not returned to the manufacturer for evaluation.The instruction for use for this compressor states "check the filter at least once a week.Replace the filter when dirty" and "the filter should be replaced when it becomes discoloured".Based on the information available, the manufacturer concludes that user misuse/mishandling was the cause of the event, and that no further action is necessary.

• Brand Name: OPTIONHOME COMPRESSOR
• Type of Device: COMPRESSOR, AIR PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO202 FT; UK PO202FT
• Manufacturer Contact: alessandro agosti ; chichester business park city; tangmere; chichester, PO202-FT ; UK PO202FT ; 8704231549
• MDR Report Key: 5518748
• MDR Text Key: 40930836
• Report Number: 9681154-2016-00005
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 1060509
• Device Catalogue Number: 1059751
• Device Lot Number: 10M-0728
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2010
• 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
• Patient Age: 14 YR