MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INVACARE STRATOS COMPACT; COMPRESSOR, AIR, PORTABLE

Model Number IRC1710

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

(b)(4).The manufacturer received information alleging compressor had exposed wires.The device has not been returned to date to allow further investigation.The user manual for this device states "never operate this product with a damaged cord or plug, if it is not working properly, if it was dropped or damaged, or if it was dropped into water".This device is not life sustaining or life supporting.There was no reported harm or injury alleged to the patient.If supplemental information becomes available to the manufacturer at a later date, a follow up report will be filed.

Manufacturer Narrative

The manufacturer initially received information alleging compressor had exposed wires.However, when the device was returned to the distributor for evaluation, it was apparent that although the strain relief on the mains cord was broken, the insulation on the wires remained intact, and there was no actual exposed conductor.The device may have been damaged by the end user, as the strain relief appeared to be damaged through excessive force/abuse.The user manual for this device states "never operate this product with a damage cord or plug, if it is not working properly, if it was dropped or damaged, or if it was dropped in water".No further follow-up reporting will be provided for this issue unless new information becomes available.

• Brand Name: INVACARE STRATOS COMPACT
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO202 FT; UK PO202FT
• Manufacturer Contact: alessandro agosti ; chichester business park city; tangmere; chichester, PO202-FT ; UK PO202FT ; 8704231549
• MDR Report Key: 5223015
• MDR Text Key: 31180235
• Report Number: 9681154-2015-00016
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K042483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1710
• Device Catalogue Number: IRC1710
• Device Lot Number: 122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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