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

Catalog Number UNK_MED

Device Problems Bent (1059); Break (1069)

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

Event Date 04/09/2013

Event Type  malfunction  

Event Description

It was reported that the rear cross bar was broken/bent.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the rear cross bar was broken/bent.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was originally reported that the rear cross bar was broken/bent.It was found on evaluation that the recliner was not reclining due to the broken rear crossbar.This will result in an annoyance only issue as the patient could be assisted by caregiver and the recliner still supported patient weight.No sharp edges reported.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3656708
• MDR Text Key: 4314770
• Report Number: 0001831750-2014-01971
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2014
• 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