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

Model Number DSX700H11C

Device Problems Contamination (1120); Pressure Problem (3012)

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 01/01/2017

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch report (mw5102804) from a user alleging the dreamstation auto bipap caused air trapping in her abdomen with bloating after a hiatal hernia repair surgery.After reduction of air pressure on the machine with continued bloating, an emergency surgery was performed due to a new hiatal hernia with bowel obstruction.The surgeon felt that the pressure from the bipap contributed to the bowel becoming stuck in her new hernia.The pulmonologist prescribed another pressure reduction to a non-therapeutic level which greatly reduced the bloating.The user discontinued the use of the dreamstation auto bipap due to the recall and is using an older non-philips machine at a higher pressure and is no longer experiencing bloating.The device has yet to be returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received serial number of device.The user requested a new shipping label to return device since she misplaced the one that was sent to her.A final report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: the manufacturer was 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 previously received a voluntary medwatch report (mw5102804) from a user alleging the dreamstation auto bipap caused air trapping in her abdomen with bloating after a hiatal hernia repair surgery.After reduction of air pressure on the machine with continued bloating, an emergency surgery was performed due to a new hiatal hernia with bowel obstruction.The surgeon felt that the pressure from the bipap contributed to the bowel becoming stuck in her new hernia.The pulmonologist prescribed another pressure reduction to a non-therapeutic level which greatly reduced the bloating.The user discontinued the use of the dreamstation auto bipap due to the recall and is using an older non-philips machine at a higher pressure and is no longer experiencing bloating.The reported event of large hiatal hernia that had pulled over half of patient's stomach through the diaphragm and abdominal bloated and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally observed that scratches on top, unknown brown residue on knob, white dust deposits in blower outlet, white deposits in filter hole, debris consistent with dust in bottom of inside of device, white dust was observed o ring and top of blower and water marks on bottom of blower.The manufacturer used a fitt (foam integrity test tool) and was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation and there is no visible damage or functionality failures of the device.The ma nufacturer observed dust contamination and water marks in the device and are consistent with being from an external source.Section h6 type of investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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 15206 ; 2673970028
• MDR Report Key: 12476335
• MDR Text Key: 271537532
• Report Number: 2518422-2021-03690
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female