MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER30INLITTER; STRETCHER, WHEELED POWERED

Catalog Number 1125000030

Device Problem Intermittent Loss of Power (4016)

Patient Problems Pain (1994); Muscle/Tendon Damage (4532)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

It was reported during the transport of a patient with a staff member at the head end of the stretcher pushing with the motorized drive engaged and another staff member at the foot end pulling the stretcher, the drive system failed and turned off.It was reported that the floor inclined and was also un-level when the motorized drive system failed and turned off.This resulted in the staff member who was pulling the stretcher to receive a shoulder injury.

Manufacturer Narrative

The customer was contacted regarding the alleged incident.The customer reported that they were unable to provide any further information surrounding the alleged injury and event that took place and they did not require any further follow up regarding the incident.The product was not made available for further evaluation.The catalog number, serial number, 510k number and manufacturing date have been added to the corresponding fields.H3 other text : device was not accessible for evaluation.

Event Description

It was reported during the transport of a patient with a staff member at the head end of the stretcher pushing with the motorized drive engaged and another staff member at the foot end pulling the stretcher, the drive system failed and turned off.It was reported that the floor inclined and was also un-level when the motorized drive system failed and turned off.This resulted in the staff member who was pulling the stretcher to receive a shoulder injury.

• Brand Name: PRIME ZOOM STRETCHER30INLITTER
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17219641
• MDR Text Key: 318050439
• Report Number: 0001831750-2023-00674
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1125000030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2022
• 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
• Patient Outcome(s): Other