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

Model Number 1109289

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

(b)(4).The mfr rec'd info alleging ain innospire mini compressor failed during treatment.The pt alleged she was on a plane and as soon as the plane landed, she was taken to the hosp.

Manufacturer Narrative

The device has not yet been returned to the mfr for eval.At this time, we are unable to confirm the alleged info.A follow-up report will be submitted when the unit has been rec'd and the mfr's investigation is complete.

Manufacturer Narrative

Device not returned to manufacturer, therefore unable to confirm the alleged fault.Device is not life sustaining/supporting.It is concluded that no further action is required unless additional information is presented/supplied to the manufacture.

• Brand Name: INNOSPIRE MINI
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): 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: 4843946
• MDR Text Key: 19809655
• Report Number: 9681154-2015-00010
• 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,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1109289
• Device Catalogue Number: 1109289
• Device Lot Number: 140415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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