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

Model Number HS456

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/03/2017

Event Type  Injury  

Event Description

A patient returned their inspiration elite compressor device to a pharmacy, stating that they were not getting any mist from the device, and that the fan did not move.It was confirmed at that time that there was no patient harm.Three days later, it was reported that the patient had been admitted to hospital for wheezing due to the nebulizer not working properly.The patient was discharged home and was fine, although they have subsequently been re-hospitalised for a different issue, not related to any breathing problem.The compressor was returned for evaluation, and was found to be fully functional.The associated nebuliser was not returned.Internal reference (b)(4).

• Brand Name: INSPIRATION ELITE
• 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 PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 6299878
• MDR Text Key: 66456397
• Report Number: 9681154-2017-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2017

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: HS456
• Device Catalogue Number: HS456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization