MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD NOT KNOWN; COMPRESSOR, AIR, PORTABLE

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 01/09/2016

Event Type  malfunction  

Event Description

Philips internal reference number: (b)(4).Patient alleged that "she tried two different nebulizers and neither one was working, nebulizers were not providing enough medication".It is reported that the patient was admitted to hospital due to exacerbation of her copd.The manufacturer has made numerous attempts for the return of the device/s for investigation.To date, no product has been received therefore the allegation of malfunction cannot be confirmed.The model(s) of nebulizer in this event has not been advised by the patient, however none of the devices manufactured by the manufacturer are life-supporting or life-sustaining.There is no harm or injury reported, during last communication with patient she stated that "she was feeling better but still hospitalized".If supplemental information becomes available to the manufacturer at a later date, a follow up report will be filed.

• Brand Name: NOT KNOWN
• 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: 5416800
• MDR Text Key: 37675818
• Report Number: 9681154-2016-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NOT KNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR