MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 26; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034600

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

The patient was on the stretcher in preparation for a surgical procedure which was delayed so the patient could receive a precautionary ct scan.It was confirmed that the patient did not sustain any serious injuries as a result of the fall.The customer stated that the patient had a bruise on their head that was treated with an ice pack.

Event Description

It was reported that a patient fell as a result of the mattress sliding off the stretcher litter deck.It was confirmed that the patient did not sustain any serious injuries as a result of the fall.

Manufacturer Narrative

The user facility confirmed that no staff was in the room to witness the patient fall.The patient did not sustain any serious injuries and only had a bruise on the head as a result of the fall.The bruise was treated with an ice pack and a ct scan was done as a precautionary measure, no medication was dispensed.Communication with the user facility identified that the customer was not satisfied with the velcro design and that there was no component level issues or defects alleged.

Event Description

It was reported that a patient fell as a result of the mattress sliding off the stretcher litter deck.It was confirmed that the patient did not sustain any serious injuries as a result of the fall.

• Brand Name: ULTRA COMFORT, SE 4 X 26
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7544033
• MDR Text Key: 109489968
• Report Number: 0001831750-2018-00501
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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: No Information
• Device Catalogue Number: 1704034600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2017
• 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