MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000730

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

It was reported that the ottoman will not support the weight of the patient's legs/feet.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

A stryker field service representative reached out to the customer to schedule and evaluation for this device to confirm the alleged event.However, upon contact with the customer, the customer alleged that there was no component level defect with this unit and that the chair had since been returned to regular circulation so the inspection was unable to be performed.The customer further reported that no further assistance was needed at this time.Unit unavailable for evaluation.

Event Description

It was reported that the ottoman will not support the weight of the patient's legs/feet.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: PATIENT ROOM WALL SAVER RECL
• 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: 6681867
• MDR Text Key: 79036842
• Report Number: 0001831750-2017-00285
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3500000730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2017
• 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