MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO RENAISSANCE 26 OBS 10/25/04; STRETCHER, WHEELED

Catalog Number 1210000000

Device Problems Break (1069); Device Slipped (1584); Component Missing (2306); Naturally Worn (2988)

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

Event Date 01/29/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the reduced brake force due to worn damaged casters.It was also reported that the side rail could become unlatched during use due to missing compression springs.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 reduced brake force due to worn damaged casters.It was also reported that the side rail could become unlatched during use due to missing compression springs.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Previously, it was reported that there was reduced brake force due to worn and damaged casters.Upon completion of the manufacturer's investigation it was confirmed that the wear on the casters did not affect the function of the brakes and the brakes were able to engage and hold.

• Brand Name: RENAISSANCE 26 OBS 10/25/04
• Type of Device: STRETCHER, WHEELED
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3636356
• MDR Text Key: 4178550
• Report Number: 0001831750-2014-01500
• Device Sequence Number: 1
• Product Code: FPO
• 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: 01/29/2014

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: Other
• Device Catalogue Number: 1210000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2014
• 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