MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO C2500MS & M2500 LAL/APM; BED, FLOTATION THERAPY, POWERED

Catalog Number P2500

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Physical Entrapment (2327)

Event Date 03/26/2016

Event Type  malfunction  

Event Description

It was reported that a patient allegedly had their head stuck between the siderail and mattress taking several staff members to pull them out.The event involved a stryker mattress and non-stryker bed.It was confirmed that the mattress in use was too small for the bed frame.No additional information has been provided.

Manufacturer Narrative

A visual and functional inspection was allegedly performed by a third party repair facility.The alleged inspection found that a patient was laying in bed and fell out through the large space between the rails and the mattress.The nurse was outside the door and was able to assist the patient, and there was no alleged injury or medical intervention required.It was found that the mattress was on a gendron bed, which has the dimensions of 39" w, 80" l, and is adjustable up to 48" wide.The mattress on the unit has the dimensions of 34" w and 80" l.This indicates that this mattress is too small for the bed, and may allow for wide gaps that a patient could fall through.The issue was resolved for the customer by advising the customer to use the mattress on an appropriately sized bed.Device evaluated by a third party repair facility.

Event Description

It was alleged that a patient was laying in bed and fell out through the large space between the rails and the mattress.The nurse was outside the door and was able to assist the patient, and there was no alleged injury or medical intervention required.

• Brand Name: C2500MS & M2500 LAL/APM
• 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: 5615228
• MDR Text Key: 43893956
• Report Number: 0001831750-2016-00132
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: P2500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• 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