Device product
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
Z-1139-2019
Product summary
- Event
- Event 82531
- Status
- Completed
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-1139-2019
Official wording
Reason: Malfunction warming pad.
Code information: Lot Number 27473 Quantity in lots 12 Part Number PIN-BH85, Lot Number 27590 Quantity in lots 6 Part Number PIN-SKY67-OS, Lot Number 27544 Quantity in lots 2 Part Number PIN-LG78-OS, Lot Number 27634 Quantity in lots 3 Part Number PIN-SUMMIT, and Lot Number 27498 Quantity in lots 1 Part Number PIN-PEDS
Distribution pattern: US Distribution to state of: Wisconsin.
Derived failure modes
-
Unknown
Malfunction warming pad.