MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; BED, FLOTATION THERAPY, POWERED

Catalog Number 2860000000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

The safety director at the user facility stated that the injury seems to have occurred due to the practice of using one staff member to place an x-ray cassette under a patient (rather than 2 staff members to assist with turning), which may cause more stress on that person.Device malfunction not alleged.

Event Description

It was reported that the customer feels the cover of the mattress is too "tacky" and they find it difficult to slide x-ray cassettes under the patients.It was further alleged a staff member sustained a shoulder injury as a result.The staff member reportedly was seen by a doctor, but no details regarding the extent of the alleged injury were reported.

• Brand Name: ISOFLEX LAL 2860
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6038468
• MDR Text Key: 57774719
• Report Number: 0001831750-2016-00322
• Device Sequence Number: 1
• Product Code: IOQ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2016

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: 2860000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/18/2016
• 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