MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE CONNECT LOCATOR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	521200380100
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.29 devices were functionally/visually inspected in the field.However, there was no product malfunction; the issue was the result of user error.3 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 32 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.
Additional Manufacturer Narrative
The final 3 devices that were pending evaluation were not made available by the customer; the reported issue was not confirmed.
Event or Problem Description
This report summarizes 32 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.

• Brand Name: SECURE CONNECT LOCATOR
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12238229
• Report Number: 0001831750-2021-01210
• Device Sequence Number: 17355559
• Product Code: FNL
• UDI-Device Identifier: 07613327520453
• UDI-Public: 07613327520453
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 32
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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
• Operator of Device: No Information
• Device Model Number: 521200380100
• Device Catalogue Number: 521200380100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1