MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PSYCH FLORENCE MANUAL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number	FL23P
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2018
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; the devices had damaged components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the units had reduced brake force.There was no patient involvement.

• Brand Name: PSYCH FLORENCE MANUAL
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8009848
• Report Number: 0001831750-2018-01191
• Device Sequence Number: 11199208
• Product Code: FNL
• UDI-Device Identifier: 00670482000029
• UDI-Public: 00670482000029
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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 Catalogue Number: FL23P
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1