MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-18 for SPIRIT PLATFORM 5800000000 manufactured by Stryker Medical London Dba Chg Hospital Beds.
[97675423]
It was reported that this event resulted in a worker's compensation claim, but no details regarding the claim were given.
Patient Sequence No: 1, Text Type: N, H10
[97675424]
It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury. It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given. No defects were alleged with the bed, and no patient involvement was reported.
Patient Sequence No: 1, Text Type: D, B5
[113308744]
No defects were alleged with the unit, and the issue was resolved for the customer by confirming no further assistance was required.
Patient Sequence No: 1, Text Type: N, H10
[113308745]
It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury. It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given. No defects were alleged with the bed, and no patient involvement was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006433555-2018-00016 |
| MDR Report Key | 7203674 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-18 |
| Date of Report | 2018-03-16 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2015-01-16 |
| Date Added to Maude | 2018-01-18 |
| 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 LONDON DBA CHG HOSPITAL BEDS |
| Manufacturer Street | 1020 ADELAIDE ST. S. |
| Manufacturer City | N6E 1R6 |
| 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 | 2018-01-18 |
| Catalog Number | 5800000000 |
| Device Availability | Y |
| Device Age | DA |
| 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. N6E 1R6 CA N6E 1R6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-18 |