MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for SPIRIT PLATFORM 5800000000 manufactured by Stryker Medical London Dba Chg Hospital Beds.
[93311029]
No malfunction of the device is alleged.
Patient Sequence No: 1, Text Type: N, H10
[93311030]
It was reported that a patient used the restraints and the restraint strap bracket as a ligature in an attempt to self-harm. However, it was confirmed that there was no serious injury or harm to the patient as a result of the alleged event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006433555-2017-00197 |
| MDR Report Key | 7065194 |
| Date Received | 2017-11-28 |
| Date of Report | 2018-04-06 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KRISTEN CANTER |
| 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 | 0 |
| Brand Name | SPIRIT PLATFORM |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2017-11-28 |
| 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 | 2017-11-28 |