MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE MINI WITH BATTERY (AUS); NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 1111452

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

The manufacturer received information that an end user required hospitalization for two days as a result of a malfunction of an innospire mini nebulizer.The date of the alleged event is unknown.There was no other information provided.The manufacturer's investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the device for investigation.There was evidence the device blower had malfunctioned, resulting in the delivered pressure being below specification.There was evidence of dirt/hair contamination internally to the device.There were no electrical issues noted.The innospire mini is intended to provide a source of compressed air for medical purposes.It is to be used with a pneumatic (jet) nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.Labeling included with this device warns the user "it is recommended to have a backup device (e.G.Mdi) for respiratory delivery in case a situation arises when your nebulizer cannot be used (e.G.During a power outage or if your compressor and/or battery becomes inoperable for any reason.).This device is not labeled for life support.Although the user reported being hospitalized for 2 days, there has been no further information provided as to the reason for the admission.There was no serious or permanent injury reported.Based on the information available, the manufacturer concludes no further action is required.

• Brand Name: INNOSPIRE MINI WITH BATTERY (AUS)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, uk PO20 2FT; UK PO20 2FT
• MDR Report Key: 8138047
• MDR Text Key: 129491067
• Report Number: 9681154-2018-00021
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1111452
• Device Catalogue Number: 1111452
• Device Lot Number: 160830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization