MAUDE Adverse Event Report: RESPIRATORY DRUG DELIVERY (UK) LTD. HS 456; COMPRESSOR, AIR, PORTABLE

Model Number HS 456

Device Problems Fire (1245); Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 03/14/2014

Event Type  Death  

Event Description

Philips internal reference no: (b)(4).The manufacturer received info alleging an hs456 compressor has caused fire to a property and there was a death (the apartment occupant) as result of the event.The device is not returning to the manufacturer but it is available for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the investigation is complete.

Manufacturer Narrative

(b)(4).The manufacturer has performed a visual inspection of the compressor that appears as an agglomeration of plastic and metal fused together.However, there are still rubber components within the compressor remains indicating that very likely the compressor sustained external heat that distorted the plastic device before thermally damaging any of the interior components.From the available pictures of the apartment after the fire was extinguished, it appears that in the same room where the compressor have been found it was present an oxygen concentrator and clear sign of "burned tubing" have been found on the floor very close to where the compressor was found.This indicates that the oxygen concentrator was running at the time of the event.It is likely that the compressor power cord plug was connected to the power socket however is not possible to determine if the device was energized or not at the time of the event.If the hs456 compressor was running at the same time oxygen concentrator was operating this would be in contradiction to the warning in the instruction for use of the device that states to "do not use outdoors or operate where aerosol (spray) products are being used or where oxygen is being administered in a closed area such as an oxygen tent".In the eventuality that the compressor was not running at the time of the event with the plug left connected to the power socket it would be in contradiction to one of the "important safeguards" in the instruction for use of the device that calls: "always unplug the product immediately after using".Hs456 is no longer in production.No further follow-up reporting will be provided for this issue unless new information became available.Correction: manufacturer report number in the initial report was 9681154-2015-00011 and it was not correct.Right number is 9681154-2015-00014.

• Brand Name: HS 456
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): 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; tangmere; chichester, PO202-FT ; UK PO202FT ; 8704231549
• MDR Report Key: 5005253
• MDR Text Key: 23097077
• Report Number: 9681154-2015-00014
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Not Applicable
• Type of Report: Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HS 456
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2009
• 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): Death