MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for ISOLIBRIUM SUPPORT SURFACE - N 2971000000 manufactured by Stryker Medical-kalamazoo.
[107892478]
The nurse manager indicated she believed the injury may be attributed to the mattress cycling out of prevention mode. She was informed by a stryker quality assurance engineer that the mattress may leave prevention mode if the power of the unit is cycled and patient therapy settings are not reselected. The nurse manager reported the account is working on training measures to educate nurses to check to make sure the bed is in prevention mode. No device malfunction is alleged.
Patient Sequence No: 1, Text Type: N, H10
[107892479]
It was reported the patient developed a stage 3 pressure injury while on the mattress. The nurse manager reported the injury was treated using venelex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00470 |
| MDR Report Key | 7503572 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-08 |
| Date Added to Maude | 2018-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARY KLAVER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLIBRIUM SUPPORT SURFACE - N |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2018-05-10 |
| Catalog Number | 2971000000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-10 |