MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BASIC CONFIGURATION MODEL PRIME X 5TH WHEEL 1105000000X; STRETCHER, WHEELED

Catalog Number 1105XBASIC

Device Problems Failure To Adhere Or Bond (1031); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the mattress could not adhere to the litter surface due to missing velcro piles.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The issue was resolved for the customer by replacing the missing velcro piles.

Event Description

It was reported via repair work order that the mattress could not adhere to the litter surface due to missing velcro piles.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: BASIC CONFIGURATION MODEL PRIME X 5TH WHEEL 1105000000X
• Type of Device: STRETCHER, WHEELED
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3653883
• MDR Text Key: 19767102
• Report Number: 0001831750-2014-01889
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2014

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: Other
• Device Catalogue Number: 1105XBASIC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 02/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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