MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 5TH WHEEL STRETCHER, PRIME X; STRETCHER, WHEELED

Model Number	1105
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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.1 device was functionally/visually inspected in the field.This device was repaired and returned to use.1 device is pending investigation.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 brakes were difficult to engage/disengage. there was no patient involvement.
Event or Problem Description
This report summarizes 1 malfunction events, where it was reported the brakes were difficult to engage/disengage.  there was no patient involvement.
Additional Manufacturer Narrative
Upon inspection of one of the devices it was determined the device experienced the issue of having to use an alternate pedal to engage brakes, which is not reportable.

• Brand Name: 5TH WHEEL STRETCHER, PRIME X
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11239645
• Report Number: 0001831750-2021-00328
• Device Sequence Number: 17146528
• Product Code: FPO
• UDI-Device Identifier: 07613327278194
• UDI-Public: 07613327278194
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 03/17/2021

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: 1105
• Device Catalogue Number: 1105000000X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 01/01/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1