Brand Name | ARJO ROTOPRONE BED |
Type of Device | BED, PATIENT ROTATION, POWERED |
Manufacturer (Section D) |
ARJO / ARJOHUNTLEIGH POLSKA SP. ZO.O. |
|
|
MDR Report Key | 10148402 |
MDR Text Key | 195002304 |
Report Number | MW5094974 |
Device Sequence Number | 1 |
Product Code |
IKZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/08/2020 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/12/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/22/2020 |
Is the Reporter a Health Professional? |
No
|
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 60 YR |
Patient Weight | 85 |
|
|