MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number AUX1131T15C

Device Problem Electrical Shorting (2926)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2020

Event Type  malfunction  

Event Description

The manufacturer received information alleging a power cord sparked and caught fire.There was no report of patient harm or injury.The device has yet to be returned to the manufacturer's service center for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a power cord allegedly sparked and caught fire.There was no report of patient harm or injury.The power cord was returned to the manufacturer's quality product investigation laboratory for evaluation.The manufacturer was able to confirm thermal damage/melting to the insulation proximal to the male end of the ac power cord.With manipulation, it is possible to make contact with the exposed lead.It appears the power cord was exposed to forces beyond its intended design.Product labeling states," periodically inspect electrical cords, cables, tubing, and accessories for damage or signs of wear.Discontinue use and replace if damaged.".

• Brand Name: DREAMSTATION BIPAP AVAPS30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 10482737
• MDR Text Key: 205978462
• Report Number: 2518422-2020-02015
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AUX1131T15C
• Device Catalogue Number: AUX1131T15C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1