Augustine Temperature Management, Llc
15305 Minnetonka Blvd, Minnetonka, MN, US
Registered product codes
3 product codes
Recent MDR events
13 on file
- B500 UNIVERSAL BLANKETJan 2, 2025Injury3005857264-2024-00003
- HOTDOG TEMPERATURE MANAGEMENT CONTROLLER MULTIPORT AND 2-PANEL MULTI-POSITION BLJul 1, 2024MalfunctionMW5156876
- HOTDOG TEMPERATURE MANAGEMENT CONTROLLER MULTIPORT AND 2-PANEL MULTI-POSITION BLJul 1, 2024MalfunctionMW5156877
- HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50")Jun 14, 2024Injury3005857264-2024-00002
- HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50")Apr 19, 2024Injury3005857264-2024-00001
- HOT DOG WARMING CONTROLLERFeb 16, 2024MalfunctionMW5151770
- HOTDOG PATIENT WARMINGSep 15, 2022MalfunctionMW5112088
- HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLERDec 21, 2021Malfunction13051708
- HOT DOG PATIENT WARMING SYSTEM MULTIFUNCTION CONTROLLERDec 21, 2021Malfunction13051709
- HOTDOG PATIENT WARMING BLANKETDec 15, 2021InjuryMW5106110
Recalls
13 on file
- Open, ClassifiedFeb 20, 2025
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
View FDA record ↗ - Open, ClassifiedFeb 20, 2025
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
View FDA record ↗ - Open, ClassifiedFeb 20, 2025
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
View FDA record ↗ - Open, ClassifiedFeb 14, 2025
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
View FDA record ↗ - Open, ClassifiedFeb 14, 2025
Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .
View FDA record ↗ - CompletedJan 10, 2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
View FDA record ↗ - CompletedJan 10, 2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
View FDA record ↗ - CompletedJan 10, 2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
View FDA record ↗ - CompletedJan 10, 2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
View FDA record ↗ - CompletedJan 10, 2025
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
View FDA record ↗
Compliance history
Matched by FEI 3005857264.
FDA inspections
2 on file
- Official Action Indicated (OAI)Nov 27, 2024
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Nov 27, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(1)Nov 27, 2024
Report of Death or Serious Injury
- 21 CFR 806.10(a)(1)Nov 27, 2024
Report of risk to health
- 21 CFR 820.30(g)Nov 27, 2024
Design validation- Lack of or inadequate procedures
- 21 CFR 820.80(d)Nov 27, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.100(a)Nov 27, 2024
Lack of or inadequate procedures
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.