MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-30 for ELITE CARE CLINER W/SWING AWAY ARMS 6940 manufactured by Winco Mfg Llc.
[16850221]
On (b)(6) 2014 winco customer svc rec'd a call from (b)(6), area tech operations mgr for fresenius medical care. He informed us that a 6940 elite care cliner had overheated during a pt treatment and left a burn pattern on the chair back cushion and the pts pillow. The pt initially had red marks on his back similar to a sunburn. The pt refused to go to the hosp. Upon completion of dialysis, the pt had only a small red mark on his back. Pt rec'd no medical care for the red marks (b)(4). The facility refused repeated requests from winco to return the recliner for eval for approximately one month.
Patient Sequence No: 1, Text Type: D, B5
[17081111]
The facility contacted winco about the incident, by phone, on 12/31/2014 but refused to return the chair to winco for eval until 01/29/2015. This is the "becomes aware" date that we used. On 02/27/2015, advised clinic to inspect their remaining recliners for worn or incorrectly installed wiring harness.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1027229-2015-00001 |
| MDR Report Key | 4647435 |
| Report Source | 07 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-02-27 |
| Date of Event | 2014-12-31 |
| Date Mfgr Received | 2014-12-31 |
| Device Manufacturer Date | 2010-11-19 |
| Date Added to Maude | 2015-05-08 |
| 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 | JAIME ACEVEDO |
| Manufacturer Street | 5516 S.W. FIRST LN. |
| Manufacturer City | OCALA FL 34474 |
| Manufacturer Country | US |
| Manufacturer Postal | 34474 |
| Manufacturer Phone | 3528542926 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE CARE CLINER W/SWING AWAY ARMS |
| Generic Name | CLINICAL RECLINER, 6940-19-TB-HM |
| Product Code | FRJ |
| Date Received | 2015-03-30 |
| Model Number | 6940 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO MFG LLC |
| Manufacturer Address | 5516 S.W. FIRST LN. OCALA FL 34474 US 34474 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-30 |