MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE 3 MED/SURG ZOOM BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	3002
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the malfunction summary reporting program, exemption number e2014007.The devices were evaluated in the field and the issue was confirmed.2 devices required calibration; 1 device had a misaligned component.There were no remedial actions taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 3 malfunction events, where it was reported the zoom surged during use.No patients were involved.

• Brand Name: SECURE 3 MED/SURG ZOOM BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 7453543
• Report Number: 0001831750-2018-00304
• Device Sequence Number: 1446093
• Product Code: FNL
• UDI-Device Identifier: 07613327278385
• UDI-Public: (01)07613327278385
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 3002
• Device Catalogue Number: 3002S3ZOOM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1