Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Recall
- Recall Number
- Z-1508-2025
- Event Number
- 96414
- Firm
- PYRAMES INC
- FEI Number
- 3014466900
- Product Code
- DXN
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- February 24, 2025
- Posted
- April 2, 2025
- Address
- 21730 Stevns Crk Blvd, Ste 201a, Cupertino, CA, 95014-1171
Description
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
The firm sent a MEDICAL DEVICE CORRECTIONS NOTTICE" dated 3/5/2025 to its customers describing the product, problem and actions to be taken. Starting on 2/24/2025, the firm started providing training to users to inform them of the following: Signal may be green, but high frequency noise appears superimposed on pulse waveform signal. Containment actions: 1) Ensure that ventilator lines do not physically touch the isolette (e.g. mattress, side rails, pillow) or baby. 2) Move Boppli to patient's foot. On 3/7/2025, correction notices were emailed to customers who in addition to the above were asked to do the following: 3) Use cuff measurement(s) to confirm that the signal is no longer affected by the high-frequency oscillatory ventilation (HFOV) interference. 4) Share this notice with anyone who needs to be made aware within the organization and forward to any organization where potentially affected devices have been transferred. 5) If these actions do not mitigate the issue, discontinue using the affected blood pressure monitoring device. Firm will be releasing a new version of software that will recognize the HFOV interference, indicate its presence by changing the signal color to red, and exclude that data from BP calculations. It is expected that this solution will be implemented by April 30, 2025. The Instructions for Use (55-0001 Rev. E) was updated to include warnings of vibratory interference, what it looks like and what to do when it is identified. Please contact [email protected] or 408-569-5215 for further information.
US distribution to states of: MA and CA
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