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Philips Garbin Ventilator, Model Number 1058180B recallZ-0884-2023 · Philips Respironics, Inc. · initiated Dec 7, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

FDA root cause category: Process design

What the company is doing

Telephone calls and URGENT Medical Device Recall notification letters were distributed beginning 12/6/22. Actions you must take as a device owner or healthcare provider to prevent risks for patients. Device is on patients: For affected Trilogy 100 and Trilogy 200 devices that are on patients, ensure that your clinical assessment of the patients is up to date, reflecting the true acuity of the patients and their respiratory therapy requirements. Your patient may experience serious harm if their device malfunctions and immediate intervention is not available. Until Philips Respironics is able to correct this problem you must adhere to the instructions below. Further instructions are provided below for devices that are not on patients. For ventilator dependent patients: 1. Consider transitioning ventilator dependent patients to an alternative life-support ventilator if, as determined by the clinical assessment for the individual patient in consultation with the patient s healthcare provider, a malfunction would lead to serious injury if timely access to a backup ventilator is not possible. 2. Quarantine all impacted devices that are removed from service. 3. Please indicate which Serial Numbers must be removed from service in exchange for an alternative device For all other patients: 1. Ensure that device alarm settings are configured appropriately for your patient s needs, with special consideration for the alarms listed below. Ensure that alternative ventilation equipment is available, as appropriate to patient need, in case of emergency issues with alarms that cannot be resolved. 2. Ensure that backup monitoring is configured as required by the clinical assessment. Pulse oximetry, ECG, heart rate, blood pressure, or respiratory rate may provide additional advanced warning of and lead to faster intervention if hypoxemia were to occur. If these accessories are prescribed, ensure patients advised of proper use. 3. Consider using an inline bacterial filter which ma

Recall details

Recall number
Z-0884-2023
Status
Open, Classified
Initiated by the company
Dec 7, 2022
Posted by the FDA
Jan 6, 2023
Recalling firm
Philips Respironics, Inc.
Quantity
9
Product code
CBK
FDA submissions
K083526
Distribution
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.

Product description

Philips Garbin Ventilator, Model Number 1058180B

Code information (models, lots, serial numbers)

UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E

Other devices under the same FDA submission

23 devices cleared under K083526 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91293).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page