MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LIT SUR PIEDS ROUL SUP CHASSIS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL14E3

Device Problems False Reading From Device Non-Compliance (1228); Device Operates Differently Than Expected (2913)

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

Event Date 06/16/2015

Event Type  malfunction  

Event Description

It was reported via repair work order that the scale was inaccurate due to faulty load cells.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: LIT SUR PIEDS ROUL SUP CHASSIS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4896076
• MDR Text Key: 6535784
• Report Number: 0001831750-2015-00323
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Report Date: 06/16/2015

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: FL14E3
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/07/2015
• 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