MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-21 for ISOLIBRIUM SUPPORT SURFACE - D 2972000000 manufactured by Stryker Medical-kalamazoo.
[128105309]
The mattress was evaluated and no malfunctions or defects were found. The customer reported that the footboard may have been removed which would have caused the mattress therapy to stop.
Patient Sequence No: 1, Text Type: N, H10
[128105310]
It was reported the patient's skin broke down on the mattress.
Patient Sequence No: 1, Text Type: D, B5
[131583740]
Through discussion with the account, it was found that the patient developed a blister on their sacrum that was treated with petroleum gauze and an over-the-counter foam. This is considered to be an s2 event, and not a serious injury.
Patient Sequence No: 1, Text Type: N, H10
[131583741]
It was reported the patient's skin broke down on the mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01442 |
| MDR Report Key | 8096614 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-21 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2018-11-21 |
| 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 - D |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2018-11-21 |
| Catalog Number | 2972000000 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-21 |