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

Model Number 1125

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.3 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 4 malfunction events.Where it was reported, the devices experienced mattress slides off litter.There was 1 event with patient involvement the patient experienced a fall and pain.

Manufacturer Narrative

Add 510k number.

Event Description

This report summarizes 4 malfunction events, where it was reported the devices experienced mattress slides off litter.There was 1 event with patient involvement the patient experienced a fall and pain.

Event Description

This report summarizes 4 malfunction events, where it was reported the devices experienced mattress slides off litter.There was 1 event with patient involvement the patient experienced a fall and pain.

Manufacturer Narrative

The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated to reflect this.

• Brand Name: PRIME ZOOM STRETCHER, ELECTRIC
• Type of Device: 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16796329
• MDR Text Key: 313834256
• Report Number: 0001831750-2023-00358
• Device Sequence Number: 1
• Product Code: INK
• UDI-Device Identifier: 07613327278286
• UDI-Public: 07613327278286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140095
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1125
• Device Catalogue Number: 1125000000E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1