MAUDE Adverse Event Report: JOERNS HEALTHCARE RECOVERCARE RCULTRA HI-LO 850 BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number RCUHLB850

Device Problems Bent (1059); Break (1069); Thermal Decomposition of Device (1071); Material Discolored (1170); Fire (1245); Cut In Material (2454); Sparking (2595); Noise, Audible (3273)

Patient Problem Shock (2072)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

A patient was sitting up in bed and being assisted with her meal by a nursing assistant.A tray table was across the bed with the assistant standing on the side.There was a loud noise, with a ball of fire and sparks from the bed.The episode lasted a few seconds.The assistant ran to get the nurses to help.An rn reported smelling burning.They removed the patient from the bed and placed her in a chair.A new bed was obtained.The patient reported a small spark to her left elbow and shock to her fingers tips.She was assessed by an md.The clinical engineering department evaluated the bed.There was a gash in the power cord of the mattress' air compressor.(photo available).The black wire was cut and burnt.There was rust color discoloration on the sheathing of the power cord that matched the rust on the bar which stops the bed's decent.The cord was cut when the bed descended onto the descent limiting bar while the cord was between the two.The grounding plug of the prong of the air pump was sheared off and the other two prongs were bent.The bed passes grounding and leaking test.Recommend design that re-routes the power cords to avoid pinch points on the bedframe.Auxiliary power outlets should be installed so that external air pump and other equipment can plug into the outlets.This prevents the power cords being routed through the metal bedframes.

• Brand Name: RECOVERCARE RCULTRA HI-LO 850 BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): JOERNS HEALTHCARE; 2100 design rd.; arlington TX 76014
• MDR Report Key: 6705383
• MDR Text Key: 79761627
• Report Number: 6705383
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RCUHLB850
• Device Catalogue Number: 850 3649-S
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 150