MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-30 for SPIRIT PLATFORM 5800000000 manufactured by Stryker Medical London Dba Chg Hospital Beds.
[6263139]
It was reported that the patient slid off the edge of the bed on the mattress and was found on the floor with an alleged head injury which required sutures.
Patient Sequence No: 1, Text Type: D, B5
[13701574]
The customer did not allege a malfunction with the unit and was, therefore, not evaluated. Chg hospital beds, inc. Was acquired by stryker on jan. 2, 2015.? This medwatch is being submitted late because it was identified during the? Integration and remediation activities initiated by stryker medical in conjunction with this acquisition.?? No malfunction was alleged by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006433555-2015-00309 |
| MDR Report Key | 4879376 |
| Report Source | 07 |
| Date Received | 2015-06-30 |
| Date of Report | 2012-02-08 |
| Date of Event | 2012-02-08 |
| Date Mfgr Received | 2012-02-08 |
| Date Added to Maude | 2015-06-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 LONDON DBA CHG HOSPITAL BEDS |
| Manufacturer Street | 1020 ADELAIDE ST. S. |
| Manufacturer City | N6E1R6 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | N6E 1R6 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIRIT PLATFORM |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2015-06-30 |
| Catalog Number | 5800000000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
| Manufacturer Address | 1020 ADELAIDE ST. S. N6E1R6 CA N6E 1R6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-30 |