MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-21 for ISOLIBRIUM SUPPORT SURFACE - N 2971000000 manufactured by Stryker Medical-kalamazoo.
[117694909]
In a conversation between stryker medical and an employee health nurse at the user facility, the nurse was reminded that cleaning under the mattress should utilize 2 people in order to reduce the risk of injury, as stated in the manual. The serial number of the unit involved in the reported incident was not recorded by the user facility, therefore the unit could not evaluated. However, the user facility is not alleging a product malfunction.
Patient Sequence No: 1, Text Type: N, H10
[117694910]
It was reported that an evs employee sustained an injury during a discharge cleaning. The employee reported lifted the foot end of the mattress and did not want to completely unplug and disconnect the unit before cleaning, which resulted in a strained lower back due to the weight of the mattress and pump. The injured employee has undergone physical therapy, and taken medications for pain management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00986 |
| MDR Report Key | 7800471 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-08-21 |
| 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 | 2018-08-21 |
| 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 | 2018-08-21 |