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

Model Number	1095060
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposed of by distributor.
Event or Problem Description
It was reported that this device would turn on, but not give medication.As a result, the patient attended emergency room (er) to get medicine treatment.He received 2 breathing treatments and was given a script for oral steriods.The device has not been returned for evaluation so we are unable to confirm any defect.Internal reference ra 307144548.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: 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
• MDR Report Key: 7214656
• Report Number: 9681154-2018-00003
• Device Sequence Number: 164911
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 0383730001814
• Combination Product (Y/N): N
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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
• Operator of Device: Other
• Device Model Number: 1095060
• Device Catalogue Number: 1099966
• Device Lot Number: 161128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization