MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS HEALTHCARE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DV57D-HH

Device Problems Use of Device Problem (1670); Unexpected Shutdown (4019)

Patient Problems Apnea (1720); Low Oxygen Saturation (2477)

Event Date 06/15/2023

Event Type  Injury  

Event Description

Devilbiss healthcare was notified of an incident involving a bi-level cpap by the biomedical department of a hospital, who reported the device shut down while in patient use.The patient was observed to not be spontaneously breathing after suspected aspiration.The intended use for the device is stated to be "for use in treating osa in spontaneously breathing patients 30 kg (66 lbs) and above by means of application of positive air pressure." the patient's blood oxygen level decreased to 64%.The patient was placed on a 100% non-rebreather mask and the patient's blood oxygen level increased to 70%.It is unknown if the patient required additional medical treatment.Drive devilbiss healthcare is currently investigating the incident, including attempting to retrieve the device for investigation.An update will be filed if additional information becomes available.

Manufacturer Narrative

Devilbiss healthcare previously reported an incident involving a bi-level cpap by the biomedical department of a hospital, who reported the device shut down while in patient use.The patient was observed to not be spontaneously breathing after suspected aspiration.The patient's blood oxygen level decreased to 64%.The patient was placed on a 100% non-rebreather mask and the patient's blood oxygen level increased to 70%.It is unknown if the patient required additional medical treatment.The device was evaluated and passed all testing, and was observed to be functioning properly.The smartcode data extracted demonstrated a high percentage leak, which confirms that either the mask was not worn properly or there was some type of system leak.Upon return, it was observed that the unit was not seated properly on the humidifier base, which is likely to be the root cause of the leak.There was no damage to the outside or inside of the device.Functional testing of the unit indicated that the unit was functioning within specification and the unit passed auto on/off and triggering testing.The reported event was not likely caused by a device failure as it passed all testing and was observed to be functioning properly upon receipt.

• Brand Name: DEVILBISS HEALTHCARE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 18230792
• MDR Text Key: 329278320
• Report Number: 2515872-2023-00093
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00885304000198
• UDI-Public: 885304000198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DV57D-HH
• Device Catalogue Number: DV57D-HH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention