MAUDE Adverse Event Report: JOERNS HEALTHCARE EASYCARE BED; ELECTRIC PATIENT BED

Model Number ECSBED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/12/2017

Event Type  Injury  

Manufacturer Narrative

The device was altered by the facility.

Event Description

It was reported to the manufacturer by the end user, per the end user, "we had a resident that was sent to the hospital due to a skin tare from one of our beds from joerns.After checking on the bed, i found out that there was a sharp piece on one of the side bed extenders.It seemed to be that the tubing was not sanded down around the entire tube before the black end cap went on.I did file the piece down and we are checking all other beds." the resident sustained a deep laceration to the lower right leg that required stitches.Upon speaking with the facility, they stated that "the resident was in a wheelchair and the 2 cnas were assisting the resident into bed.Once the resident was in bed, the cna's noticed that the resident was bleeding and resident said i must have bumped my leg.The transfer went as normal per the staff.The facility believes the bed caused the injury to the patient." complaint#(b)(4) was entered into our system.Since the possible area of concern was altered by the facility, the bed will not be returned as there is no way to determine root cause.

• Brand Name: EASYCARE BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 6827132
• MDR Text Key: 83873607
• Report Number: 3009402404-2017-00038
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ECSBED
• Device Catalogue Number: ECSBED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 80