MAUDE Adverse Event Report: RESPIRONICS INC. REMSTAR AUTO SERIES AFLEX; VENTILATOR, NON-CONTINUOUS, RESPIRATOR

Model Number 550P

Device Problems Cut In Material (2454); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 12/31/2014

Event Type  malfunction  

Event Description

It was alleged that a ac power cord to a continuous positive airway pressure (cpap) device had exposed wires.There was no report of patient harm or injury.

Manufacturer Narrative

The manufacturer confirmed evidence of exposed wires to the ac power cord to the associated cpap device.There was no evidence of damage to the cpap device.The manufacturer's investigation determined the event was most likely caused by physical damage to the cord when exposed to forces beyond its intended design.Labeling for this device instructs the user periodically inspect the ac power cord for wear and to replace if necessary.There is no patient harm associated with this reported event.The manufactured concludes no further action is necessary.

Manufacturer Narrative

(b)(4).

• Brand Name: REMSTAR AUTO SERIES AFLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS, RESPIRATOR
• Manufacturer (Section D): RESPIRONICS INC.; murrysville PA
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville, PA 15146 ; 7243875658
• MDR Report Key: 4475555
• MDR Text Key: 5401332
• Report Number: 2518422-2015-00207
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 550P
• Device Catalogue Number: 550P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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
• Treatment: HEATED HUMIDIFIER: SN (B)(4)