| Device Type ID | 2566 |
| Device Name | Mattress, Air Flotation, Alternating Pressure |
| Regulation Description | Alternating Pressure Air Flotation Mattress. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FNM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2566 |
| Device | Mattress, Air Flotation, Alternating Pressure |
| Product Code | FNM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Alternating Pressure Air Flotation Mattress. |
| CFR Regulation Number | 880.5550 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 123 |
Insufficient Information | 20 |
Use Of Device Problem | 19 |
Inflation Problem | 17 |
Decrease In Pressure | 15 |
Thermal Decomposition Of Device | 10 |
Device Handling Problem | 8 |
Electrical /Electronic Property Problem | 7 |
Improper Or Incorrect Procedure Or Method | 6 |
Human Factors Issue | 6 |
Air Leak | 6 |
Failure To Power Up | 6 |
No Pressure | 6 |
Computer Software Problem | 6 |
No Audible Alarm | 5 |
Deflation Problem | 5 |
Sparking | 4 |
Component Falling | 4 |
Material Separation | 4 |
Unclear Information | 4 |
Installation-Related Problem | 3 |
Inadequate Or Insufficient Training | 3 |
Device Issue | 3 |
Electrical Shorting | 3 |
Break | 3 |
Device Operational Issue | 3 |
Fire | 3 |
No Apparent Adverse Event | 3 |
Smoking | 2 |
Structural Problem | 2 |
Burst Container Or Vessel | 2 |
Device Inoperable | 2 |
Improper Flow Or Infusion | 2 |
Entrapment Of Device | 2 |
Defective Alarm | 2 |
Pressure Problem | 2 |
Peeled / Delaminated | 2 |
Off-Label Use | 2 |
Loss Of Power | 2 |
Use Of Incorrect Control Settings | 1 |
Folded | 1 |
Unintended Movement | 1 |
Detachment Of Device Component | 1 |
Device Maintenance Issue | 1 |
Device Damaged Prior To Use | 1 |
Disconnection | 1 |
Overheating Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
Product Quality Problem | 1 |
Defective Component | 1 |
Compatibility Problem | 1 |
Material Integrity Problem | 1 |
Power Problem | 1 |
Human-Device Interface Problem | 1 |
Misassembled During Installation | 1 |
Device Tipped Over | 1 |
Physical Property Issue | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Material Puncture / Hole | 1 |
Overfill | 1 |
Misassembled | 1 |
Increase In Pressure | 1 |
Failure To Reset | 1 |
Activation Failure Including Expansion Failures | 1 |
Circuit Failure | 1 |
| Total Device Problems | 353 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American National Mfg Inc | II | Aug-19-2016 |
| 2 | SCM True Air Technologies LLC | II | May-19-2014 |
| 3 | Stryker Medical Division Of Stryker Corporation | II | Mar-08-2016 |