MAUDE Adverse Event Report: SAFE-T-CARE AMBASSADOR 1200 BED; ELECTRIC PATIENT BED

Model Number AMB1200

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

Patient Problem Laceration(s) (1946)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to the manufacturer by the end user, per the end user the patient was getting into bed and hit his leg on a bar on the side of the bed.It put a small cut on his leg.The patient required a wound dressing and compression bandage.(b)(4) were 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: AMBASSADOR 1200 BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): SAFE-T-CARE; 5802 gardendale dr; houston TX 77092
• Manufacturer (Section G): SAFE-T-CARE; 5802 gardendale dr; houston TX 77092
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5903336
• MDR Text Key: 52964730
• Report Number: 3009402404-2016-00033
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AMB1200
• Device Catalogue Number: AMB1200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• 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: 70 YR
• Patient Weight: 159