BiPAP V30 Auto Ventilator, Part Number 1111178

FDA device recall Z-1812-2024 · posted 2024-05-24 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

Reason for recall

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Action taken

The firm notified customers via mailed URGENT Medical Device Recall notice on March 26, 2024. The notice described the product, problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that: 1. The device is appropriately set for patient requirements. 2. Alternate ventilation equipment is available. 3. Alternative monitoring (such as alarming Pulse Oximeter or Respiratory) is used where appropriate. Depending on the level of ventilatory support required, customers were advised to place patients on an alternate source of ventilation. Philips is currently investigating the issue. If you need any further information or support concerning this issue, please contact your local Philips Respironics representative: 1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com. A second "URGENT Medical Device Recall" notice was distributed to customers on June 12, 2024. In the notice customers were provided additional guidance on how to operate the device when a Ventilator Inoperative Alarm occurs and how to perform an optional hard reboot of their device that will temporarily restore functionality. A third "URGENT Medical Device Recall" notice was distributed to customers on October 4, 2024. In the notice customers are informed of the updated intended use indications for affected devices and when use of devices is appropriate.

Root cause

Device Design

Status

Open, Classified

Product code

MNS

Quantity affected

5,958 US; None OUS

Distribution

Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia,

Date initiated

2024-03-26

Date posted

2024-05-24

Location

Murrysville, PA