MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME5TH/WHEEL ELECT STRETCHER; STRETCHER, WHEELED

Model Number 1105

Device Problem No Audible Alarm (1019)

Patient Problems Abrasion (1689); Aneurysm (1708)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that the battery failed on the stretcher and the chaperone alarm was not able to be activated.Due to the alarm not being activated, the patient fell out of the stretcher which resulted in broken ribs and an aneurysm.Attempts are being made to gather additional injury and treatment details from the user facility.

Manufacturer Narrative

The investigation is completed.Section h codes and b5 have been updated.H3 other text : the device was not made available.

Event Description

It was reported that the battery failed on the stretcher and the chaperone alarm was not able to be activated.Due to the alarm not being activated, the patient fell out of the stretcher which resulted in broken ribs and an aneurysm.The device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.

• Brand Name: PRIME5TH/WHEEL ELECT STRETCHER
• Type of Device: STRETCHER, WHEELED
• 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 millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13003700
• MDR Text Key: 282231348
• Report Number: 0001831750-2021-01648
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278279
• UDI-Public: 07613327278279
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1105
• Device Catalogue Number: 1105000000E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: No
• 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