MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034300

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2018

Event Type  malfunction  

Event Description

It was reported that the mattress slid off the stretcher during a patient transfer due to the velcro becoming unattached.It was confirmed that no injury resulted from the event.

Manufacturer Narrative

The customer did not allege any component level defect with the product.

Event Description

It was reported that the mattress slid off the stretcher during a patient transfer due to the velcro becoming unattached.It was confirmed that no injury resulted from the event.

Event Description

It was reported that the mattress slid off the stretcher during a patient transfer due to the velcro becoming unattached.It was confirmed that no injury resulted from the event.

• Brand Name: ULTRA COMFORT, SE 4 X 30
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7962655
• MDR Text Key: 123678974
• Report Number: 0001831750-2018-01091
• 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,Followup
• Report Date: 02/01/2019
• 2 Devices were Involved in the Event: 1 2

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: 1704034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 09/17/2018; 09/17/2018
• Supplement Dates FDA Received: 11/14/2018; 02/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2018
• 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