MAUDE Adverse Event Report: SPAN MEDICAL PRODUCTS CANADA SPAN AMERICA REXX; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number QD2250MLF

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

Initial email exchange/conversation between (b)(4), region manager, (b)(4) representing manufacturer and mr.(b)(4), administrator and ms.(b)(4), director of resident care representing complainant took place early morning on (b)(6) 2018.On monday (b)(4), (b)(4) and (b)(4) (manufacturer representatives) visited the health care facility to investigate and evaluate the medical device involved in the incident and interview the facility staff in regards the incident.The bed, the assist rail, and the mattress found to be complaint with (b)(4) and fda guidelines.The mattress in use was from other manufacturer.The mattress identification label was not present.At the time of the incident the bed height was 27" measured from the top of the mattress.The lowest position on this bed model is about 14".The back section of the bed was articulated between 15° and 30°.The rail assist device used is very narrow device mounted in the middle section of the bed for the purpose to facilitate easy resident ingress and egress.The incident was due to no fault of the bed.The bed in question was manufactured and conforms to iec60601-2-38, medical electrical equipment part 2: particular requirements for the safety of electrically operated hospital beds, standard.The product is certified by (b)(4), (b)(4) approved cb testing laboratories.The bed and mattress was entrapment tested by the facility on august, 3, 2017.(b)(4) will take no further action and considers this the final report submission.

Event Description

Resident, ((b)(6) year old female) reached towards the left side of the bed and consequently rolled out of the bed at approximately 9:30 pm est.Resident cried for help and staff found her sitting on the floor with her left arm caught between the assist rail and the mattress.The resident was admitted to the hospital for evaluation and treatment.The event resulted in a fractured humerus treated by a temporary local immobilization.No surgical intervention was required.Before the resident was released from the hospital (the next day).

• Brand Name: SPAN AMERICA REXX
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SPAN MEDICAL PRODUCTS CANADA; 4658 ontario st.; beamsville, L0R 1 B4; CA L0R 1B4
• Manufacturer (Section G): SPAN MEDICAL PRODUCTS CANADA; 4658 ontario st.; beamsville, L0R 1 B4; CA L0R 1B4
• Manufacturer Contact: william darby ; 70 commerce center; greenville, SC 29615 ; 8646786936
• MDR Report Key: 7345555
• MDR Text Key: 102714016
• Report Number: 8022290-2018-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: QD2250MLF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• 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: 99 YR