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

Model Number 750P

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 02/27/2014

Event Type  Death  

Event Description

A durable medical equipment (dme) supplier reported a death of a pt who was using a bi-level positive airway pressure (bipap) device.The event occurred as a result of a staff member in a skilled nursing facility unplugging the bipap from power and neglecting to remove the mask from the pt.There was no allegation of device malfunction.

Manufacturer Narrative

The mfr received the bipap and associated humidifier for evaluation.There were no operational issues noted.The devices functioned as designed and passed testing.The intended use of bipap device is only for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 66 pounds.The short-term loss of therapy for this pt class does not pose a significant health or safety risk.This is not a life support device.Although a death was reported, the mfr concludes the device functioned as designed and did not cause or contribute to the event.User error was reported.No further action is necessary.

• Brand Name: BIPAP AUTO
• 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: 3804462
• MDR Text Key: 4525188
• Report Number: 2518422-2014-00601
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 750P
• Device Catalogue Number: 750P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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, PN 1056215, SN (B)(4)
• Patient Outcome(s): Death