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

Model Number RDD480

Device Problem Device Inoperable (1663)

Patient Problem Asthma (1726)

Event Date 05/13/2014

Event Type  Injury  

Event Description

The mfr received info that allegedly a minielite compressor was charged for 16 hours and failed to operate.Thereafter, the pt allegedly suffered from an asthma attack and had to seek treatment in hospital.It was confirmed from the pt that there was no permanent pt injury or harm.The device has not yet been returned to the mfr for eval.At this time, we are unable to confirm the alleged incident.A follow-up report ill be submitted when the manufacturer's investigation is complete.

• Brand Name: MINIELITE COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY GROUP (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 PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 3876024
• MDR Text Key: 4461509
• Report Number: 9681154-2014-00009
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RDD480
• Device Catalogue Number: 13M0098
• Device Lot Number: 13M0098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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