MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. MICRO ELITE DELUXE; COMPRESSOR, AIR, PORTABLE

Model Number RDD491

Device Problem Failure to Deliver (2338)

Patient Problem Pneumonia (2011)

Event Date 10/14/2014

Event Type  Injury  

Event Description

The mfr received info that allegedly a pt received no treatment from her micro elite device.Pt was allegedly admitted into hosp as she had contracted pneumonia.(b)(4).

Manufacturer Narrative

According to info received from the pt, she indicates that she has used the same nebulizer since 2011 and is currently is hosp with pneumonia.She allegedly sates that it is as a result of not being able to use her nebulizer.Device is not life sustaining/supporting.The pt has been contacted on three separate occasions for the return of the device with no response; therefore, we are unable to confirm if the device malfunctioned or not.Complaint cannot be verified.The mfr believes it will be unable to gather additional info.The mfr is submitting a final report at this time.If pertinent info becomes available to the mfr at a later date, an addendum to this final report will be filed.

• Brand Name: MICRO ELITE DELUXE
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, west sussex ; UK
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex ; UK ; 704231549
• MDR Report Key: 4249768
• MDR Text Key: 21092275
• Report Number: 9681154-2014-00031
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K063103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RDD491
• Device Catalogue Number: RDD491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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