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

Catalog Number 2971000000

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

Patient Problem Injury (2348)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

There is no product malfunction alleged, and the serial number of the unit was not reported to the sales representative.Multiple attempts have been made to contact the user facility for more information about the reported event, but those attempts have not been successful.The sales rep indicated that the nursing assistant did not have the surface at max inflate and did not use the handy tube device (not manufactured by stryker) when trying to boost the patient.The sales rep further stated that over 400 staff members had recently been in-serviced on the product, but he was not sure if the nursing assistant involved in the incident had been in-serviced.

Event Description

It is reported that a nursing assistant was injured while boosting a heavy patient on an isolibrium surface.The severity of the alleged injury is not known.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - N
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8691918
• MDR Text Key: 147774219
• Report Number: 0001831750-2019-00590
• Device Sequence Number: 1
• Product Code: IKZ
• UDI-Device Identifier: 07613327278392
• UDI-Public: 07613327278392
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2971000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/12/2019
• 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