Brand Name | BREEZE |
Type of Device | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
Manufacturer (Section D) |
ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB |
arjohuntleigh house |
houghton hall business park |
houghton regis, bedfordshire LU5 5 XF |
UK LU5 5XF |
|
Manufacturer (Section G) |
ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB |
arjohuntleigh house |
houghton hall business park |
houghton regis, bedfordshire LU5 5 XF |
UK
LU5 5XF
|
|
Manufacturer Contact |
kinga
stolinska
|
ul. ks. wawrzyniaka 2 |
komorniki, 62-05-2, P
|
PL
62-052, PL
|
|
MDR Report Key | 7937605 |
MDR Text Key | 122820246 |
Report Number | 3005619970-2018-00012 |
Device Sequence Number | 1 |
Product Code |
FNM
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/05/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/05/2018 |
Distributor Facility Aware Date | 09/11/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/05/2018 |
Initial Date Manufacturer Received |
09/11/2018
|
Initial Date FDA Received | 10/05/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 93 YR |
|
|