MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Device Emits Odor (1425); Smoking (1585); Sparking (2595); Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

Corrective and preventative actions have been opened by the manufacturer to address the water ingress identified upon investigation.

Event Description

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device sparked, smoked and there was hot electric burning odor.Device is not functioning.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory (pil) for evaluation.An external and internal inspection of the device and observed the following: the back of the display had potential black and brown burn marks on it and the ribbon cable had a potential brown burn mark on it along with light white residue resembling potential mineral deposits.Q3 (phase b) of the motor circuitry, on the pca (printed circuit assembly), was blown apart along with surrounding components.On the pca, the following components and the area near them had potential brown corrosion on them: c50, q4.U4, c41, d21, c153, d6, d4, q1, vr1, c28, u13, q13, j5, d20, d22, and d14 on the pca, the following areas had white residue, resembling potential mineral deposits on them: q3, u4, c36, vr1, q13, d22, and j5.The through hole resistor r248 from the underside of the pca, had one of its leads completely out of the via of the pca, most likely due to extreme heat that may have reflowed some solder.Tiny unknown white and black specs of contamination at the air inlet of the blower box.The contamination found at the air inlet was most likely external to the device.The potential mineral deposits on the pca, signal moisture was inside of the device that was most likely caused by condensation.Potential moisture getting into the device where the pca is located and is believed to be the primary cause of the customer complaint.

Manufacturer Narrative

The manufacturer previously received information alleging the dreamstation 2 advanced auto cpap device sparked, smoked and there was hot electric burning odor.Device is not functioning.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory (pil) for evaluation.An external and internal inspection of the device and observed the following: the back of the display had potential black and brown burn marks on it and the ribbon cable had a potential brown burn mark on it along with light white residue resembling potential mineral deposits.Q3 (phase b) of the motor circuitry, on the pca (printed circuit assembly), was blown apart along with surrounding components.On the pca, the following components and the area near them had potential brown corrosion on them: c50, q4.U4, c41, d21, c153, d6, d4, q1, vr1, c28, u13, q13, j5, d20, d22, and d14 on the pca, the following areas had white residue, resembling potential mineral deposits on them: q3, u4, c36, vr1, q13, d22, and j5.The through hole resistor r248 from the underside of the pca, had one of its leads completely out of the via of the pca, most likely due to extreme heat that may have reflowed some solder.Tiny unknown white and black specs of contamination at the air inlet of the blower box.The contamination found at the air inlet was most likely external to the device.The potential mineral deposits on the pca, signal moisture was inside of the device that was most likely caused by condensation.Potential moisture getting into the device where the pca is located and is believed to be the primary cause of the customer complaint.The manufacturer is submitting a correction report for section h: problem code, evaluation results code and conclusion code.

• Brand Name: DS2ADV AUTO CPAP
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17743572
• MDR Text Key: 323374922
• Report Number: 2518422-2023-22853
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male