MAUDE Adverse Event Report: SPAN MEDICAL PRODUCTS CANADA ULC REXX; BED

Model Number RAD306H

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 06/26/2022

Event Type  Injury  

Event Description

Resident was reaching for his phone that fell off and went in between the mattress and the rail and his right arm was caught between the bed and the mattress.

Manufacturer Narrative

The resident was reaching for his phone that fell off and went in between the mattress and the rail.His right arm was caught between the bed and the mattress.There was a faint abrasion on the right inner forearm immediately after the incident that was resolved quickly.No medical intervention was performed.Otherwise, there has been no significant open area nor there was any bruising resulting from the incident.There was no significant pain reported.No significant change in locomotion and overall health status resulting from the incident.The mattress in use with the bed was a span america geomattress and was compatible.Date of manufacture 10-03-2017.The bed and mattress are in good condition.Email exchange/conversation between (b)(6), director of quality and mr.(b)(6), director of care, (b)(6) was initiated on (b)(6) 2022.The conversation revealed that the bed, the assist rail, and the mattress are compliant with entrapment health canada and fda guidelines.The mattress in use was span america geomattress, date of manufacture 10-03-2017.Based on the details of the incident, the resident intentionally forced their hand in between the flexible mattress and the rail in order to attempt retrieval of their phone.There are patient entrapment warning labels are used on all beds and entrapment hazards are explained in all use and care manuals.The bed and rails are design to meet fda/health canada entrapment guidelines as well as entrapment iec 60601-2-52 rules.If the forearm were oriented toward the bed, there are only two potentially sharp edges however both are powder painted which softens the edges.If the forearm were oriented away from the bed, one possible sharp edge is the formed end of a semi-tubular rivet in rad306h.The risk analysis addresses sharp edges and corners and the risk has been mitigated as low as reasonably practical using manufacturing instructions and in-process inspection.Rexx beds designed to meet entrapment guidelines per iec 60601-2-52.Patient entrapment warning labels are used on all beds.Entrapment hazard explained in all use and care manuals.No further action required.

• Brand Name: REXX
• Type of Device: BED
• Manufacturer (Section D): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer (Section G): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer Contact: erika ramsbottom ; 4658 ontario street; beamsville, ontario L0R 1-B4 ; CA L0R 1B4
• MDR Report Key: 15327255
• MDR Text Key: 298965982
• Report Number: 8022290-2022-00002
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RAD306H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other