MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EYE SURGERY STRETCHER OBS 3/07; STRETCHER, WHEELED

Catalog Number 1069000000

Device Problems Mechanical Problem (1384); Component Missing (2306); Unintended Movement (3026)

Patient Problem Headache (1880)

Event Date 05/11/2016

Event Type  Injury  

Event Description

It was reported that the wrist rest moved during use with a patient and hit the patient in the head.The patient complained of head pain and was sent to urgent care, further information on the outcome of the patient has not been provided.The device was evaluated by a field service technician who identified that there was no defect with the wrist rest assembly and that it was functioning to specifications.The field service technician did identify that the siderail could unlatch during use due to missing latch springs, however this would not contribute to the wrist rest moving unintentionally.

Manufacturer Narrative

It was reported that the patient had pain in the head as a result of the alleged event and was prescribed pain medication.The customer stated that the wrist rest was likely not locked into place by the user which may have contributed to the alleged event.

Event Description

It was reported that the wrist rest moved during use with a patient and hit the patient in the head.The patient complained of head pain and was sent to urgent care.The device was evaluated by a field service technician who identified that there was no defect with the wrist rest assembly and that it was functioning to specifications.The field service technician did identify that the siderail could unlatch during use due to missing latch springs, however this would not contribute to the wrist rest moving unintentionally.

• Brand Name: EYE SURGERY STRETCHER OBS 3/07
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5716853
• MDR Text Key: 47101844
• Report Number: 0001831750-2016-00191
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1069000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2004
• 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