MAUDE Adverse Event Report: RESPIRONICS INC REMSTAR PRO W/C-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number IN461S

Device Problems Misconnection (1399); Arcing (2583)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

The mfr was notified by a customer that a power supply to a continuous positive airway pressure (cpap) device was "faulty".There was no pt harm reported.

Manufacturer Narrative

The mfr received the power supply and dc and ac power cords only from the facility.The mfr noted that thermal damage had occurred to the power supply and power cord, resulting in an exposed wire on the ac power cord.There was no thermal damage reported to the cpap device itself, and it was not returned for evaluation.The mfr's investigation determined the thermal event was most likely caused by a partial connection of the ac power cord to the ac input of the power supply by the user.Labeling for this device instructs the user to ensure that all connections are secure when operating the device using ac power.There is no pt harm associated with this reported event.The mfr concludes no further action is necessary.

• Brand Name: REMSTAR PRO W/C-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; murrysville PA
• Manufacturer Contact: roger hyde ; 1740 golden mile hwy; monroeville, PA 15146 ; 7243875690
• MDR Report Key: 3915834
• MDR Text Key: 4489075
• Report Number: 2518422-2014-00856
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IN461S
• Device Catalogue Number: IN461S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2014
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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