MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for AFFINITY THREE P3700 manufactured by Hill-rom Industries.
[37733515]
Patient Sequence No: 1, Text Type: N, H10
[37733516]
Patient was attempting to sit up at edge of bed to have epidural catheter removed. Patient had baby in arms and was getting ready to hand baby to nurse (myself) when lower end of labor bed fell. Patient was hit with lower end of bed on her buttock area but did not fall on the floor. Patient was on her feet after lower end of bed fell and i had the baby and handed baby to the father of the baby. Patient was ambulatory and standing while i placed lower portion of labor bed in place and patient then ambulated to bathroom to void, change gown and pericare with no complaints. Patient then ambulated back to bed and lay in bed with no complaints. Bed reported to engineering for evaluation. Manufacturer response for hospital bed, birthing, affinity p3700 (per site reporter): manufacturer contacted to investigate and provide follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5418703 |
| MDR Report Key | 5418703 |
| Date Received | 2016-02-09 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-12-19 |
| Report Date | 2015-12-22 |
| Date Reported to FDA | 2015-12-22 |
| Date Reported to Mfgr | 2015-12-22 |
| Date Added to Maude | 2016-02-09 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | AFFINITY THREE |
| Generic Name | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2016-02-09 |
| Model Number | P3700 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM INDUSTRIES |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-09 |