MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE 3 MED/SURG BEDOBS 01/13; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3002S3EX

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/04/2015

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to contact the customer for further information regarding this event.A supplemental report will be submitted once additional information is known.No device malfunction alleged.

Event Description

It was reported by a voluntary medwatch report that allegedly a s3 bed had a first step mattress and a patient was found to have his head/neck wedged in-between top siderail and headboard of bed.The medwatch did not indicate if any adverse event was alleged.

Manufacturer Narrative

Upon conclusion of the investigation, it was determined this complaint was entered in error, as it was a complaint that had previously been reported to stryker medical.The previous complaint was reported via asr reporting, as it was confirmed that no patient injury had resulted from this alleged event, and no actual product malfunction had occurred.

Event Description

It was reported by a voluntary medwatch report that allegedly a s3 bed had a first step mattress and a patient was found to have his head/neck wedged in-between top siderail and headboard of bed.The medwatch did not indicate if any adverse event was alleged.

• Brand Name: SECURE 3 MED/SURG BEDOBS 01/13
• 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: 5039063
• MDR Text Key: 24423772
• Report Number: 0001831750-2015-00406
• 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: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/31/2015

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: 3002S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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