MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for STANLEY HEALTHC 73030 manufactured by Stanley Healthcare.
[105328132]
Pt was found on floor by staff. Pt had been placed in geriatric chair with alarm pad underneath pt. Chair alarm did not alarm when pt exited chair unassisted. Staff responded. Upon inspection of chair alarm, chair pad was not functioning properly. Pt transferred to higher level of care. Results revealed acute bilateral subarachnoid hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7420896 |
| MDR Report Key | 7420896 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-03-29 |
| Date Facility Aware | 2018-03-29 |
| Report Date | 2018-04-04 |
| Date Reported to FDA | 2018-04-04 |
| Date Reported to Mfgr | 2018-04-04 |
| Date Added to Maude | 2018-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STANLEY HEALTHC |
| Generic Name | CHAIR SENSORMAT PAD |
| Product Code | FRJ |
| Date Received | 2018-04-05 |
| Model Number | 73030 |
| Lot Number | AG0617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY HEALTHCARE |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2018-04-05 |