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

Model Number 700M

Device Problems Moisture Damage (1405); Improper or Incorrect Procedure or Method (2017); Electrical Shorting (2926); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

A durable medical equipment supplier (dme) reported that a thermal event resulted in a void in the top enclosure of a bilevel positive airway pressure device (bipap).There was no report of harm or injury.The manufacturer determined there were signs of water ingress to the electronic components inside the bipap, leading to a short circuit and subsequent thermal damage and compromise of the top enclosure.The product's labeling provides user care and handling instructions to prevent water ingress from occurring or affecting the operation of the device.The manufacturer concludes that user mishandling/abuse caused or contributed to the failure of the device and that no further action is necessary.

• Brand Name: BIPAP AUTO M-SERIES
• Type of Device: VENTILATOR, NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville 15146 ; 7243875658
• MDR Report Key: 4867983
• MDR Text Key: 6057502
• Report Number: 2518422-2015-01727
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050759
• 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: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700M
• Device Catalogue Number: 700M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2009
• 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
• Treatment: HEATED HUMIDIFIER PN1051158, SN (B)(4).