MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR HEATED HUMIDIFIER; VENTILATOR NONCONTINUOUS RESPIRATOR

Model Number 1005792

Device Problems Device Operational Issue (2914); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

A durable med equipment supplier (dme) reported that an ac power cord to a heated humidifier device had experienced a thermal event while in use with its associated bi-level positive airway pressure (bipap).There was no pt harm or injury reported.

Manufacturer Narrative

The visual inspection of the returned humidifier determined thermal damages to the device's power cord as well as to humidifier' pca (printed circuit assembly).There was visual evidence of water ingress outside and inside the humidifier.The mfr concluded that the water ingress caused corrosion to the humidifier pca (printed circuit assembly), which caused a thermal event affecting the pca and the device's power cord.There was no evidence of damage to the bipap device.The device's user manual provides instructions to the user to prevent water to enter the device.There is no pt harm associated with this reported event.The mfr concludes no further action is necessary.

• Brand Name: REMSTAR HEATED HUMIDIFIER
• Type of Device: VENTILATOR NONCONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC.; murrysville PA
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile hwy; monroeville, PA 15146 ; 7243875658
• MDR Report Key: 4502635
• MDR Text Key: 5352757
• Report Number: 2518422-2015-00262
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1005792
• Device Catalogue Number: 1005792
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: (BI-LEVEL POSITIVE AIRWAY PRESSURE),; SERIAL NUMBER (B)(4), PN 1042907; BIPAP AUTO SV ADVANCED,