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

Catalog Number 2972000000

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

It was reported that the users were having difficulty getting x-ray cassettes under patients.It was reported that the patient had a "do not turn order" but they had to be turned anyway to get the cassettes in the correct position.The user allegedly experienced shoulder pain in his ac joing, but did not take time off of work and required no medical intervention.Further, it was reported that there were no adverse consequences or clinically relevant delay in treatment for the patient.

Manufacturer Narrative

The issue was resolved for the customer by the sales rep working with the customer regarding the best method to take x-rays with patients on this surface.

Event Description

It was reported that the users were having difficulty getting x-ray cassettes under patients.It was reported that the patient had a "do not turn order" but they had to be turned anyway to get the cassettes in the correct position.The user allegedly experienced shoulder pain in his ac joint, but did not take time off of work and required no medical intervention.Further, it was reported that there were no adverse consequences or clinically relevant delay in treatment for the patient.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the users were having difficulty getting x-ray cassettes under patients.It was reported that the patient had a "do not turn order" but they had to be turned anyway to get the cassettes in the correct position.The user allegedly experienced shoulder pain in his ac joint, but did not take time off of work and required no medical intervention.Further, it was reported that there were no adverse consequences or clinically relevant delay in treatment for the patient.

• 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: 6909180
• MDR Text Key: 88116903
• Report Number: 0001831750-2017-00426
• 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: user facility
• 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: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• 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