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

Catalog Number FL23SE

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Stryker medical is filing this emdr as the initial importer for the device.(b)(4) is the manufacturer of the device.

Event Description

It was reported that the bed slides on the floor when the brake position is engaged.It was further reported a nurse injured his back during a patient transfer, but no details regarding the severity of the alleged injury were provided.

Manufacturer Narrative

Conclusion from manufacturer (b)(4), found that the brakes were performing to specification however, it was observed that the bed was sliding slightly across the waxed linoleum floor.

Event Description

It was reported that the bed slides on the floor when the brake position is engaged.It was further reported a nurse injured his back during a patient transfer, but no details regarding the severity of the alleged injury were provided.

• Brand Name: ELECTRIC 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5101356
• MDR Text Key: 26678885
• Report Number: 0001831750-2015-00443
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 09/24/2015,08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FL23SE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2015
• Distributor Facility Aware Date: 08/25/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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