MAUDE Adverse Event Report: JOERNS HEALTHCARE CARE 100 BED; PATIENT BED

Model Number ECCBED

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 05/11/2020

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, that employee was fixing a motor on a bed in room 34.He was lying on his back underneath the bed when a piece fell and struck him on his left eye.Complaint (b)(4) was entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: CARE 100 BED
• Type of Device: PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; 5001 joerns drive; stevens point, wi
• Manufacturer (Section G): JOERNS HEALTHCARE; 2100 design road; arlington, tx
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, tx ; 8260270316
• MDR Report Key: 10328455
• MDR Text Key: 200496159
• Report Number: 3009402404-2020-00025
• 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: 06/26/2020

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: Other
• Device Model Number: ECCBED
• Device Catalogue Number: ECCBED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/27/2020
• 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: 45 YR
• Patient Weight: 86