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

Catalog Number 3500000705

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/31/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the front left caster was broken off.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was originally reported that the front left caster was broken off.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.Upon further investigation it was concluded that he unit was at the receiving dock at the hospital prior to the repair and no patients would have access to the chair.The unit was not placed into service prior to the repair when it arrived at the hospital.The issue reported is not likely to contribute to serious injury or death as this service report does not require an mdr because the failure was noticed out of box and not put into service.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported via repair work order that the front left caster was broken off.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3775150
• MDR Text Key: 4527641
• Report Number: 0001831750-2014-02935
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3500000705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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