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

Catalog Number FL17E

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

No device malfunction alleged.

Event Description

It was reported that the customer allegedly has observed that patients have been able to get their arms, legs, and necks caught in the gaps of the side rails.No specific incident has been reported, nor was there any reported adverse event.

Manufacturer Narrative

The sales rep confirmed with the customer that they have had no reported entrapment issues at this time.It was merely pointed out by the manager of the overflow unit that she felt there was some opportunity for that to happen with these beds.No further feedback was requested by the customer.

Event Description

It was reported that the customer allegedly has observed that patients have been able to get their arms, legs, and necks caught in the gaps of the side rails.No specific incident has been reported, nor was there any reported adverse event.

• Brand Name: GOBED
• 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: 7159938
• MDR Text Key: 96378880
• Report Number: 0001831750-2018-00005
• 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: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FL17E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• 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
• Patient Sequence Number: 1