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

Catalog Number	1125000000E
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In accordance with the "final guidance on medical device reporting for manufacturers" issued on november 7, 2016, stryker medical will no longer report the hazard of ground path compromised for our stretcher lines (product code ink), as this hazard has not caused or contributed to any serious injuries.While no new mdrs will be generated for this hazard moving forward, additional supplemental records may be submitted for past reported events if new information becomes available.Should a new serious adverse event occur attributed to this hazard, mdr reporting will resume.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.8 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device was not evaluated as the cause was determined by analyzing data provided by the user/third party; no further assistance was requested by the customer.1 device is pending evaluation.Evaluation results findings (components/results).2 devices: circuit board / current leakage problem.7 devices: power cord / current leakage problem.1 device: appropriate term/code not available / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1-september 30, 2025.This report summarizes 10 malfunction events(s), where it was reported the devices experienced ground path compromised.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results): 1 device: power cord/current leakage problem.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The device that was originally reviewed by data, was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results): 1 device: power cord; circuit board/current leakage problem.
Event or Problem Description
No new information.

• Brand Name: PRIME ZOOM STRETCHER, ELECTRIC
• 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: 23393802
• Report Number: 0001831750-2025-99420
• Device Sequence Number: 13306823
• Product Code: INK
• UDI-Device Identifier: 07613327278286
• UDI-Public: 7613327278286
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 10
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 1125000000E
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 10/01/2025; 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 10/31/2025; 01/15/2026; 01/30/2026
• 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