MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GOBED II MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL28C

Device Problems Device Inoperable (1663); Improper Device Output (2953)

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

Event Date 02/06/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Follow-up submitted with evaluation results provided by customer which determined the scale was inaccurate due to faulty load cells.Customer sent parts to do repairs.Customer performed evaluation.

Event Description

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

• Brand Name: GOBED II MED/SURG BED
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3659792
• MDR Text Key: 4356068
• Report Number: 0001831750-2014-02035
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

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: FL28C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 03/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2014
• 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
• Removal/Correction Number: RA-2011-070
• Patient Sequence Number: 1