MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-10-14 for AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS UNKNOWN manufactured by Invacare Taylor Street.
[4873804]
Per provider when patient was being transferred from the bed the patients arm got stuck on the bed rail. Bed rail may be an aftermarket group rail per provider. Upon retrospective review this complaint has been deemed reportable due to entrapment issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2014-06954 |
| MDR Report Key | 4169947 |
| Report Source | 08 |
| Date Received | 2014-10-14 |
| Date of Report | 2013-04-26 |
| Date Mfgr Received | 2013-04-26 |
| Date Added to Maude | 2014-10-28 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN LOUGHREN |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS |
| Generic Name | 880.5100 |
| Product Code | FNJ |
| Date Received | 2014-10-14 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-14 |