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

Model Number RDD482

Device Problem Device Inoperable (1663)

Patient Problem Asthma (1726)

Event Date 06/23/2014

Event Type  Injury  

Event Description

The mfr received info that allegedly a minielite compressor failed to operate.Pt stated she could not breathe and she used her oxygen concentrator per instructions from her doctor.It was confirmed from the pt that the device caused no permanent pt injury or harm.The device is not returning to the mfr for eval.At this time, we are unable to confirm the alleged incident.Philips internal ref number: (b)(4).

Manufacturer Narrative

Pt does not know if the device operates with the battery pack of the ac/dc adapter.Device will not be returning for eval.There was no significant harm to the pt.Device is not life sustaining/supporting.As the device will not be returning for eval we are unable to determine the cause of the fault.This investigation remains inconclusive and there will be no further follow up reporting unless new info becomes available.

• Brand Name: MINIELITE COMPORESSOR
• 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 PO20 2FT; UK PO20 2FT
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex ; UK ; 704231549
• MDR Report Key: 3975802
• MDR Text Key: 4821047
• Report Number: 9681154-2014-00017
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K060404
• 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: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RDD482
• Device Catalogue Number: 12X
• Device Lot Number: 12X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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