MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARROW TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000705

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 06/28/2018

Event Type  malfunction  

Event Description

It was reported that a patient fell after leaning forward from a reclined position.The back rest was not locked, causing unexpected motion.The patient was not injured.

Manufacturer Narrative

Updated to add investigation information.Device not available for evaluation.

Event Description

It was reported that a patient fell after leaning forward from a reclined position.The back rest was not locked, causing unexpected motion.The patient was not injured.

• Brand Name: NARROW TREATMENT RECLINER
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7723779
• MDR Text Key: 115362843
• Report Number: 0001831750-2018-00902
• Device Sequence Number: 1
• Product Code: FRK
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3500000705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• 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