MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER26INLITTER; STRETCHER, WHEELED, POWERED

Catalog Number	1125000026
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event(s), where it was reported the device experienced ground path compromised.There was 1 event with patient involvement; the patient experienced a shock.
Event or Problem Description
This report now summarizes 4 malfunction event(s), instead of 1.An additional event where a patient was involved; the patient experienced an electric shock.
Additional Manufacturer Narrative
3 additional events were identified and therefore added to this summary report and are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
The devices that were pending evaluation were not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results) 3 devices: appropriate term/code not available/no findings available.
Event or Problem Description
The additional event where a patient an electric shock was reported in error.

• Brand Name: PRIME ZOOM STRETCHER26INLITTER
• Common Device Name: STRETCHER, WHEELED, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 22576177
• Report Number: 0001831750-2025-99067
• Device Sequence Number: 21257665
• Product Code: INK
• UDI-Device Identifier: 07613327278316
• UDI-Public: 7613327278316
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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 Catalogue Number: 1125000026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown