MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED

Catalog Number 2972000000

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 01/06/2017

Event Type  Injury  

Event Description

It was reported that the staff were experiencing shoulder and elbow injuries when trying to pull patients back into a seated position after they have slid down on the mattress, and also when trying to slide x-ray panels under the patient.The customer alleges that the mattress cover is too tacky, which is a customer preference issue.The extent of the injuries and any possible medical intervention was not reported.

Manufacturer Narrative

It was reported that the customer has alleged a general increase of injuries from boosting patients.However, they are not alleging any specific injuries attributed to the stryker product, and they did not allege any component malfunctions or defects with the stryker product.It was found that the nursing staff and caregivers do not always use two staff members and do not put the surface in max inflate to help with boosting and preparing the patient for x-rays.The issue was resolved for the customer by visiting the customer and the stryker clinical nurse consultant recommending that they perform these activities in max inflate with two caregivers present.

Event Description

It was reported that the staff were experiencing shoulder and elbow injuries when trying to pull patients back into a seated position after they have slid down on the mattress, and also when trying to slide x-ray panels under the patient.The customer alleges that the mattress cover is too tacky, which is a customer preference issue.The extent of the injuries and any possible medical intervention was not reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the staff were experiencing shoulder and elbow injuries when trying to pull patients back into a seated position after they have slid down on the mattress, and also when trying to slide x-ray panels under the patient.The customer alleges that the mattress cover is too tacky, which is a customer preference issue.The extent of the injuries and any possible medical intervention was not reported.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• Type of Device: BED, PATIENT ROTATION, 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: 6299896
• MDR Text Key: 66459194
• Report Number: 0001831750-2017-00026
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• 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