Device product
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007
Z-1508-2025
Product summary
- Firm
- PYRAMES INC
- Event
- Event 96414
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35
- Official record key
device-enforcement:Z-1508-2025
Official wording
Reason: 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.
Code information: Software version: 2.2.3 Part/UFI-DI/Lot: 54-0002/10860007282925/24020902, 24040302, 23103002; 51-0007/10860007282901/24011702, 24111301
Distribution pattern: US distribution to states of: MA and CA
Derived failure modes
-
Unknown
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.