MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY LE WITH ISOTOUR STD; BED, AC POWERED ADJUSTABLE HOSPITAL

Catalog Number	3009PX-LE-400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported than an employee tripped over the siderail when it was lowered and had to take worker's compensation while awaiting surgery as a result of an unspecified injury.
Event or Problem Description
It was reported than an employee tripped over the siderail when it was lowered and had to take worker's compensation while awaiting surgery as a result of a torn rotator cuff.The bed was not alleged to have had any component level defect.
Additional Manufacturer Narrative
B5 summary and section h codes updated to reflect the completed investigation.H3 other text : evaluation not requested by customer.

• Brand Name: PROCUITY LE WITH ISOTOUR STD
• Common Device Name: BED, AC POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17792946
• Report Number: 0001831750-2023-01006
• Device Sequence Number: 6454428
• Product Code: FNL
• UDI-Device Identifier: 07613327541182
• UDI-Public: 07613327541182
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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?: Yes
• Device Catalogue Number: 3009PX-LE-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown