MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-04 for SHUREMED, SCHUERCH CORPS. 800-0004 L04817289 manufactured by Schuerch Corps..
[3536559]
Shuremed powered beach chair, arthroscopy, mdr event terms code # (b)(4): procedure completed, powered beach chair, arthroscopy snapped and pt assisted to floor by crna 6 rn. Abrasion on head and left inner thigh. Note: physician notified, physician in room when incident occurred. Medical equipment used during procedure: steris surgical as 1100 pounds maximum. Powered beach chair, arthroscopy model: 800-0004, sn# (b)(4) rated as 500 pounds capacity proportional pt load (b)(6) tall pt per 99% human body model. Device shall support 500 pounds pt weight and (b)(6) tall pt. Shoulder panel shall support 50 pounds. Lateral brace shall resist 50 pounds. Purchased on (b)(6) 2009. Device shall operate for five years under normal use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030455 |
| MDR Report Key | 3151828 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-03 |
| Date of Event | 2013-04-25 |
| Date Added to Maude | 2013-06-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUREMED, SCHUERCH CORPS. |
| Generic Name | POWERED BEACH CHAIR, ARTHROSCOPY |
| Product Code | GBB |
| Date Received | 2013-06-04 |
| Model Number | 800-0004 |
| Catalog Number | L04817289 |
| Lot Number | SEM 12-2EA00-000 |
| ID Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUERCH CORPS. |
| Manufacturer Address | 50 MESSINA DR BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-04 |