MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-13 for SWING AWA ARM CARECLINER 6940 manufactured by Winco Mfg., Inc..
[18025727]
On (b)(6) 2014, winco received a call fro, (b)(4), technical operations manager with (b)(4). Mr. (b)(4) advised winco's customer care manager ((b)(4)) that one of their patient is claiming they were burned when sitting in a 6940 swing away arm carecliner while receiving treatment. The patient had been asleep in the recline position for two hours prior to the complaint. The patient reported that his chair was about to blow up and was hot. The nurse on duty examined the chair within minutes of the initial complaint. The nurse indicated that there was no vibration or warmth detected and that the operating switch was noted to be in the off position. Patient went immediately to his doctor and the doctor was unable to find any visible burn marks. The doctor advised the patient that due to his medical condition (neuropathy) if he lays down for any length of time he will feel a burning sensation on his skin. The patient advised the doctor that the chair had burnt him on the inside.
Patient Sequence No: 1, Text Type: D, B5
[18232396]
On (b)(4) 2014 advised the clinic to remove the chair from service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2014-00002 |
| MDR Report Key | 4036267 |
| Report Source | 07 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-07-07 |
| Date of Event | 2014-06-11 |
| Date Mfgr Received | 2014-07-03 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2014-08-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GEORGE ANELLO |
| Manufacturer Street | 5516 S.W. FIRST LN. |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542929 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWING AWA ARM CARECLINER |
| Generic Name | CLINICAL RECLINER |
| Product Code | FRJ |
| Date Received | 2014-08-13 |
| Returned To Mfg | 2014-07-17 |
| Model Number | 6940 |
| Catalog Number | 6940 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG., INC. |
| Manufacturer Address | 5516 S.W. FIRST LN. OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-13 |