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

Model Number ECSBED

Device Problem Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/07/2019

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, facility was transferring the resident from the wheel chair to the bed.The resident plopped down onto the bed and then told staff that his leg hurt.Staff noticed the laceration and called for assistance.Resident was transferred to the local er for evaluation.The resident sustained a laceration to the lower left leg that required sutures and staples.Complaint# (b)(4) was entered into our system.

• Brand Name: EASYCARE BED
• Type of Device: PATIENT ELECTRIC BED
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 97499 ; MX 97499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 97499 ; MX 97499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 8751382
• MDR Text Key: 149761108
• Report Number: 3009402404-2019-00042
• 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: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• 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?: No
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 78 YR
• Patient Weight: 79