MAUDE Adverse Event Report: STRYKER MEDICAL S3 MED/SURG BED; BED, PATIENT, AC POWERED

Model Number 3005S3

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

Hob (head of bed) would not elevate or descend with any of the control buttons.When any button was pressed to elevate the hob, the bed would make a humming sound.This patient was in the post operative period and having pain.The bed was repaired by clinical engineering and returned to service.

• Brand Name: S3 MED/SURG BED
• Type of Device: BED, PATIENT, AC POWERED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage, MI 49002
• MDR Report Key: 5719713
• MDR Text Key: 47203905
• Report Number: 5719713
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2016

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 Operator: Nurse
• Device Model Number: 3005S3
• Other Device ID Number: CONTROL #, 39829
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO THIS EVENT OCCURRED IMMEDIATELY POST OP
• Patient Age: 85 YR
• Patient Weight: 68