MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD FAMILY COMPRESSOR; COMPRESSOR, AIR, PORTABLE, PRODUCT CODE: CAF

Model Number 91730

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Event Description

Device was originally reported as having 'plug line issue'.On evaluation, there was clear evidence of mains cord damage, leading to exposed wires.The evaluation concluded that the device may have been damaged by the end user, as the power cord appeared to be damaged through excessive force/abuse which caused exposed wiring.It has been confirmed that there was no patient harm, and the device is not life-supporting or life-sustaining.The ifu for this device contains the warning:- 'the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option)' (b)(4).

• Brand Name: FAMILY COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE, PRODUCT CODE: CAF
• 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: 5450594
• MDR Text Key: 38651228
• Report Number: 9681154-2016-00003
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 91730
• Device Catalogue Number: 91730
• Device Lot Number: 2012-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2012
• 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