MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Unspecified Eye / Vision Problem (4471)

Event Date 10/29/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop eye issues.The patient required surgery in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop eye issues.The patient required surgery in response to the reported event.In initial report section b5 was incompletely mentioned and the updated section b5 should be- the manufacturer was previously received information alleging of having afib and low heart rate.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found no evidence of contamination.The manufacturer completed an internal visual inspection.The manufacturer found evidence of contamination in the bottom panel, blower motor as well as in the blower box and filter port as well as on the non-philips filter.The humidifier was returned to the manufacturer's product investigation laboratory for evaluation.The manufacturer found evidence of contamination in the bottom of the humidifier.The manufacturer found no evidence of sound abatement foam degradation /breakdown.The device's downloaded event log was reviewed by the manufacturer and found no errors logged.The device was applied power and the device operated properly.The manufacturer concludes there was no evidence of sound abatement foam degradation or breakdown.

• Brand Name: DREAMSTATION BIPAP ST30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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 15206 ; 2673970028
• MDR Report Key: 12860237
• MDR Text Key: 281136776
• Report Number: 2518422-2021-07138
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER DSXHCP (SN-(B)(6)).
• Patient Outcome(s): Other