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

Catalog Number 1704034600

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem Fall (1848)

Event Date 07/16/2018

Event Type  malfunction  

Event Description

It was reported that a patient allegedly fell as the result of the mattress sliding off of the litter.It was reported that this was the result of the velcro being worn and folded.No adverse consequences to the patient or caregiver were reported by the customer.

Manufacturer Narrative

Ther user facility reported that there was actually no occurrences of patient falls.It was also identified that this reported event is a duplicate of mfr report # 0001831750-2018-00929.

Event Description

It was reported that the mattress is sliding off of the litter.No adverse consequences to the patient or caregiver were reported by the customer.

• 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: 7775783
• MDR Text Key: 117014326
• Report Number: 0001831750-2018-00962
• 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: 01/10/2019

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?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/12/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 01/10/2019
• 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