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

Model Number 760P

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was alleged that the bilevel positive airway pressure (bipap) auto device had an electrical issue.Upon receipt, the manufacturer found evidence of a void to the top enclosure.There was no report of harm or injury.The manufacturer determined there were signs of water ingress to the printed circuit assembly (pca) leading to subsequent thermal damage and compormise 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
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville, PA 15146 ; 7243875658
• MDR Report Key: 4545783
• MDR Text Key: 5522002
• Report Number: 2518422-2015-00489
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

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: 760P
• Device Catalogue Number: 760P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: SYSTEM ONE HTD HUMID, SN (B)(4), PN DS6HFLG