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

Model Number DSX520H11C

Device Problem Computer Software Problem (1112)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging the dreamstation 2 advanced auto cpap device fell on the floor, service required.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for evaluation.External and internal inspection of the device and observed the following: the display ribbon cable had a black burn mark across the traces.The display had brown and black marks on it.The pca(printed circuit assembly) had q3 (phase b) of the motor circuitry blown apart along with the surrounding circuitry, with black burn marks near it.There was also potential brown corrosion in the surrounding area, near q4 and gnd5.One screw holding on the top enclosure had unknown white residue (potential mineral deposits) on the threads.There was also, white residue (potential mineral deposits) in the screw hole.The other screw holding on the top enclosure had a potential rust mark on the top of it and white residue (potential mineral deposits).One screw holding in the pca had white residue (potential mineral deposits) on its threads.There was white residue (potential mineral deposits) and black burn marks on the pca near d21 and d19.Vr1 had a black burn mark on top of it and some potential brown and black corrosion at d6, u10, d25, and q7 areas.D16 has white residue (potential mineral deposits) near it and the surrounding area.There are black burn marks near r219, c24, u19 and r100.There are black burn marks and white residue (potential mineral deposits) at the pins of j4 and j5 and the surrounding area.There was a black burn mark at the pins of p4, on the solder side.The blower motor brass nut had white residue (potential mineral deposits) on it.A blower box lid screw had white residue (potential mineral deposits) and a rust mark on the top of it and in the screw hole.There was unknown tiny white and black contamination at the air input of the blower box.The potential corrosion and unknown white residue (potential mineral deposits) indicates that moisture potentially got inside of the device, suggesting liquid ingress as the root cause.Moisture potentially dripped onto the pca causing destruction, as seen with previous dreamstation 2 investigations with similar consequences.There is visible damage or functionality failures of the device, most likely due to external conditions.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

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

• 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: 17611211
• MDR Text Key: 321825290
• Report Number: 2518422-2023-20626
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1