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

Catalog Number 3500000750

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  malfunction  

Event Description

It was reported that the recliner's backrest would not hold patient's weight.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Replacement parts were ordered for the customer as they prefer to complete the repairs themselves.

Event Description

It was reported that the rocker mechanism was broken/damaged causing the ottoman to not support patient weight.Although there was patient involvement, no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: PATIENT ROOM ROCKER 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6249137
• MDR Text Key: 65106305
• Report Number: 0001831750-2017-00014
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3500000750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2010
• 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