| Device Type ID | 122 |
| Device Name | Support, Patient Position |
| Regulation Description | Patient Position Support. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.6820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 122 |
| Device | Support, Patient Position |
| Product Code | CCX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Patient Position Support. |
| CFR Regulation Number | 868.6820 [🔎] |
| Device Problems | |
|---|---|
Air Leak | 460 |
Use Of Device Problem | 42 |
Torn Material | 33 |
Device Damaged Prior To Use | 5 |
Material Integrity Problem | 5 |
Connection Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Material Separation | 4 |
Material Deformation | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Product Quality Problem | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Increase In Pressure | 1 |
Suction Problem | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Pad | 1 |
Loss Of Or Failure To Bond | 1 |
Material Puncture / Hole | 1 |
Accessory Incompatible | 1 |
Fitting Problem | 1 |
Low Test Results | 1 |
Failure To Obtain Sample | 1 |
Out-Of-Box Failure | 1 |
Device Issue | 1 |
Component Or Accessory Incompatibility | 1 |
| Total Device Problems | 578 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Jul-07-2014 |