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

Catalog Number 2972000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

It was reported the users were experiencing a general increase in injuries to the neck, lower back and shoulders as the surface did not allow ease of use with x-ray cassettes.It was further reported that the users did not require time off work and have self-medicated.No patient was affected and no adverse consequence or clinically relevant delay in treatment for the patient was reported.

Manufacturer Narrative

It was identified that the customer believes it is difficult to position x-ray cassettes under patients on the mattress.The account manager stated that he is working with the customer to recommend best practices for positioning x-ray cassettes under patients.The serial number could not be identified.

Event Description

It was reported the users were experiencing a general increase in injuries to the neck, lower back and shoulders as the surface did not allow ease of use with x-ray cassettes.It was further reported that the users did not require time off work and have self-medicated.No patient was affected and no adverse consequence or clinically relevant delay in treatment for the patient was reported.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• Type of Device: BED, FLOTATION THERAPY, 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: 7679425
• MDR Text Key: 114014615
• Report Number: 0001831750-2018-00643
• 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
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• 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