SWING AWA ARM CARECLINER
Received Aug 13, 2014 · Event occurred Jun 11, 2014
Report 1027229-2014-00002 · MDR key 4036267
Device
Generic name
Clinical Recliner
Manufacturer
Winco Mfg., Inc.Model number
6940Catalog number
6940
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR
- Burn(s)
Narrative
Additional Manufacturer Narrative
ON (B)(4) 2014 ADVISED THE CLINIC TO REMOVE THE CHAIR FROM SERVICE.
Description of Event or Problem
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.
Remedial action
- Replace