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 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Philips internal reference no: (b)(4).The manufacturer received information alleging compressor had exposed wires.The device is not available for 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.Device manufacture date is december 2013.

• 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: 5235219
• MDR Text Key: 31566957
• Report Number: 9681154-2015-00018
• 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
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IRC1710
• Device Catalogue Number: IRC1710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1