smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA device recall Z-1274-2024 · posted 2024-03-19 · Open, Classified

Recall details

Recalling firm

Smiths Medical ASD Inc.

Reason for recall

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

Action taken

Smiths medical issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 02/07/2024 via letter using traceable means. The notice explained the issue with the device, potential risk to the patient, and requested the following actions be taken: "There is no need to return or discontinue using your paraPAC plus, at this time. When using the device, all instructions, including warnings and cautions in the User Manual Doc. numbers (10018833-003 and/or 10026347-002) must be followed with heightened awareness. This is inclusive, but not limited to the following: " Constant monitoring of the patient. " Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography. " All pre-use checks must be performed before each use. " Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction. If the paraPac plus ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation." " Customer Required Actions: 1. Please identify all paraPAC plusTM units in your possession. 2. Share this recall notification with all potential users of the devices and if the devices are used at another location. 3. Complete and return the attached Customer Response Form to smithsmedical3488@sedgwick.com. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3488@sedgwick.com." For questions about this Field Correction Notice, contact your sales representative or call 763-383-3072.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BTL

Quantity affected

10140 units

Distribution

Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Repu

Date initiated

2024-02-07

Date posted

2024-03-19

Location

Minneapolis, MN

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