| Brand Name | ILIFT POWER LIFT W/MANUAL BASE 9153652758 |
|---|
| Type of Device | LIFT, PATIENT, NON-AC-POWERED |
|---|
| Manufacturer (Section D) |
| INVACARE REHABILITATION EQUIPMENT CO. |
| no.5 weixi road, sip |
| suzhou jiangsu 2151 21 |
| CH 215121 |
|
|---|
| Manufacturer (Section G) |
| INVACARE REHABILITATION EQUIPMENT CO. |
| no.5 weixi road, sip |
|
| suzhou jiangsu 2151 21 |
|
CH
215121
|
|
|---|
| Manufacturer Contact |
|
kevin
guyton
|
| one invacare way |
| elyria, OH 44035
|
|
8003336900
|
|
|---|
| MDR Report Key | 4895964 |
|---|
| MDR Text Key | 6071693 |
|---|
| Report Number | 3008262382-2015-01459 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
FSA
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Distributor |
|---|
| Reporter Occupation |
Medical Equipment Company Technician/Representative
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
06/12/2015 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 07/07/2015 |
|---|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
Lay User/Patient
|
|---|
| Device Model Number | ILIFTEM |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Date Manufacturer Received | 06/12/2015 |
|---|
| Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
|---|
| Is the Device Single Use? |
No
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Reuse
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Outcome(s) |
Other;
|
