MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for SPR PLUS II BED CUSHION CL212 manufactured by Stryker Medical-kalamazoo.
[69446655]
Investigation results showed that the patient had fractured her wrist during a previous fall, and the customer was unable to confirm if the fracture mentioned in this report was due to the recent fall, or if it was caused by the previous fall. Also, upon evaluation of the unit, it was found that the user was over-inflating the overlay, which can reduce siderail coverage. The issue was resolved for the customer by the stryker sales representative performing an in-service to train the customer on proper use of the overlay.
Patient Sequence No: 1, Text Type: N, H10
[69446656]
It was alleged that an elderly dementia patient fell and broke her wrist. The patient received an x-ray, but no further details regarding medical intervention was reported. The customer reported that, although they do not know if the patient fell out of the bed, or if she exited the bed and then fell, they were concerned that there is inadequate siderail coverage due to the height of the mattress in relation to the height of the siderail. The customer was not able to identify the particular bed or surface related to this incident.
Patient Sequence No: 1, Text Type: D, B5
[91056200]
Investigation results showed that the patient had fractured her wrist during a previous fall, and the customer was unable to confirm if the fracture mentioned in this report was due to the recent fall, or if it was caused by the previous fall. Also, upon evaluation of the unit, it was found that the user was over-inflating the overlay, which can reduce siderail coverage. The issue was resolved for the customer by the stryker sales representative performing an in-service to train the customer on proper use of the overlay.
Patient Sequence No: 1, Text Type: N, H10
[91056201]
It was alleged that an elderly dementia patient fell and broke her wrist. The patient received an x-ray, but no further details regarding medical intervention was reported. The customer reported that, although they do not know if the patient fell out of the bed, or if she exited the bed and then fell, they were concerned that there is inadequate siderail coverage due to the height of the mattress in relation to the height of the siderail. The customer was not able to identify the particular bed or surface related to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00061 |
| MDR Report Key | 6389556 |
| Date Received | 2017-03-08 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-02-07 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-03-08 |
| 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. CHANDA BURGHARD |
| 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 | 0 |
| Brand Name | SPR PLUS II BED CUSHION |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-03-08 |
| Catalog Number | CL212 |
| 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 | 2017-03-08 |