MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for N/A manufactured by Stryker Sustainability Solutions.
[184264686]
Bedside report given. Patient sitting in chair with bedside table placed in front of patient. Patient watching tv, no complaints given states she did not want to go back to bed at that time watching tv. Chair check was intact as this rn did check with zero delay stated. 20 minutes later patient was found lying on the floor chair alarm did not sound. No chair check alarm sounding prior to finding patient on floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859544 |
| MDR Report Key | 9859544 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-05 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Brand Name | N/A |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2020-03-20 |
| Lot Number | PART # M200-C |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Manufacturer Address | 1810 WEST DRAKE DRIVE TEMPE AZ 85283 US 85283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |