MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS BEACH CHAIR POSITIONER; SUPPORT, PATIENT POSITION

Model Number	AR-1627
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has received a replacement device.The device involved in this event is being returned to the manufacturer.Investigation is ongoing.Hillrom will gather additional information on the circumstances that lead to the event.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
It was reported that during a procedure involving an intubated patient the backboard of a beach chair shoulder positioner broke in half causing the patient to fall backwards.Surgical staff immediately caught the patient leading to no injury/harm and it is additionally noted there was no delay in care from the event.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
On the 30th of june 2022, arthrex, who informed hillrom of this event, communicated that their customer would not be returning this device for repair / evaluation.The beach chair shoulder positioner is designed to position and support the patient¿s head and torso in a variety of surgical procedures included, but not limited to orthopedic surgeries like, rotator cuff, total shoulder, reverse total shoulder, slap repair and other shoulder surgery.These devices are intended to be used by healthcare professionals within the operating room setting.Do not exceed 500 lbs.(226 kg) patient weight.The serial number shows that the device was manufactured in december of 2014.This device was not received for evaluation / repair.Since the device was not returned, the allegation could not be confirmed, and the root cause could not be determined.The most likely root cause of the backboard breaking would be a combination of wear and tear of the device (due to the device being over two years beyond its design life) and customer induced damage.Although there was no patient or caregiver injury or delay in care from the reported event, hillrom considers this a reportable event because of the limited information available on the malfunction and the potential for a serious injury if it had to recur.H3 other text : device not returned by the customer.
Event or Problem Description
It was reported that during a procedure involving an intubated patient the backboard of a beach chair shoulder positioner broke in half causing the patient to fall backwards.Surgical staff immediately caught the patient leading to no injury/harm and it is additionally noted there was no delay in care from the event.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: BEACH CHAIR POSITIONER
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14285572
• Report Number: 3010216206-2022-00003
• Device Sequence Number: 20138978
• Product Code: CCX
• UDI-Device Identifier: 00888867020214
• UDI-Public: 888867020214
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AR-1627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown