MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for COMPELLA P7800 manufactured by Hill-rom, Inc..
[185053697]
Head of bed was flat turned and the patient was on his on side to do wound care when staff saw a large spark and smoke. Bed was unplugged. Appropriate personnel were notified about electrical fire. Investigation showed that the magnetic clips that hold the electric cable in place had migrated, causing the cord to become frayed and broken, potentially causing the spark and smoke.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9882518 |
MDR Report Key | 9882518 |
Date Received | 2020-03-26 |
Date of Report | 2020-02-17 |
Date of Event | 2019-11-25 |
Report Date | 2020-02-18 |
Date Reported to FDA | 2020-02-18 |
Date Reported to Mfgr | 2020-03-26 |
Date Added to Maude | 2020-03-26 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 | COMPELLA |
Generic Name | BED, AC-POWERED ADJUSTABLE HOSPITAL |
Product Code | FNL |
Date Received | 2020-03-26 |
Returned To Mfg | 2020-02-18 |
Model Number | P7800 |
Device Availability | R |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | HILL-ROM, INC. |
Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-26 |