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

Catalog Number 2860000997

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

Patient Problem Injury (2348)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

No device malfunction alleged and no sn was recorded.

Event Description

It was reported a radiology staff member injured her wrist pushing an x-ray cassette into place on the mattress by herself.The extent of the reported injury is not known.There was patient involvement, however no adverse consequence or impact to the patient was reported.

• Brand Name: ISOFLEX LAL,2860, W/MEDSURG
• 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: 7733327
• MDR Text Key: 115650698
• Report Number: 0001831750-2018-00908
• 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
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2860000997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/30/2018
• 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