MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFORTGEL SE FIRE BARR 26 IN; MATTRESS, FLOATATION THERAPY, NON-POWERED

Catalog Number 1805034601

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.37 devices were not evaluated, as the issues were identified and resolved during troubleshooting calls between the customer and stryker technical support.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 37 malfunction events, where it was reported the devices experienced the surfaces slid off the litter.There was no patient involvement.

• Brand Name: COMFORTGEL SE FIRE BARR 26 IN
• Type of Device: MATTRESS, FLOATATION 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: kaitlyn matheny ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12238036
• MDR Text Key: 263811394
• Report Number: 0001831750-2021-01173
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 37
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2021

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: 1805034601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/28/2021
• 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