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

Catalog Number 3009PX-LE-400

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 08/24/2023

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 323975038
• Report Number: 0001831750-2023-01006
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541182
• UDI-Public: 07613327541182
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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
• Date Manufacturer Received: 08/24/2023
• 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): Other