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

Model Number 1095060

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

Device disposed of by distributor.

Event 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
• 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: 7214656
• MDR Text Key: 98044134
• Report Number: 9681154-2018-00003
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 0383730001814
• Combination Product (y/n): N
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 1095060
• Device Catalogue Number: 1099966
• Device Lot Number: 161128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/24/2018
• 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
• Patient Outcome(s): Hospitalization