MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX1-3005; BED, AC POWERED ADJUSTABLE

Catalog Number	3005S3PX1
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Codes	Abrasion (1689); Head Injury (1879); Hematoma (1884)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged that the bed exit failed to alarm and the patient fell and hit their head.
Event or Problem Description
It was alleged that the bed exit failed to alarm and the patient fell and hit their head.The fall resulted in an abrasion and a small right scalp hematoma.
Additional Manufacturer Narrative
B5 summary and section h codes have been updated to reflect the completed investigation.

• Brand Name: S3 PX1-3005
• Common Device Name: BED, AC POWERED ADJUSTABLE
• 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: 19044579
• Report Number: 0001831750-2024-00356
• Device Sequence Number: 12903056
• Product Code: FNL
• UDI-Device Identifier: 07613327278378
• UDI-Public: 07613327278378
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/05/2024

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: 3005S3PX1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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