MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR EXPRESS MATTRESS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number M1000

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Laceration(s) (1946)

Event Date 09/30/2016

Event Type  Injury  

Event Description

It was reported that the patient feel out of a non-stryker bed that was using a stryker air express mattress.No malfunction with the mattress was reported.However, the patient experienced a laceration to the forehead and nose, a hematoma of the forehead, and a fractured right nasal.

Manufacturer Narrative

This issue was resolved for the customer by confirming that nothing further was needed at this time.

Event Description

It was reported that the patient feel out of a non-stryker bed that was using a stryker air express mattress.No malfunction with the mattress was reported.However, the patient experienced a laceration to the forehead and nose, a hematoma of the forehead, and a fractured right nasal.The patient was treated for these injuries.

• Brand Name: AIR EXPRESS MATTRESS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6118910
• MDR Text Key: 60622377
• Report Number: 0001831750-2016-00371
• Device Sequence Number: 1
• Product Code: IKY
• 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,Followup
• Report Date: 01/03/2017

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: M1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2011
• 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