STRYKER MX-PRO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-07 for STRYKER MX-PRO * manufactured by Stryker Medical.

Event Text Entries

[377214] While attempting to load the transport incubator into the ambulance, the stryker stretcher failed to latch in the high position. The staff member suffered a back injury as a result. An investigation shows that the latching mechanism was working properly, however the end of the transport incubator had slid down over the release handle, causing it to jam. A similar incident was documented about 1 year ago. The design of the stretcher does not have any protection against this from happening. Inspection of three other identical units all showed deep scratch marks on the release handles, indicating contact with the transport incubator.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 590502
• MDR Report Key: 590502
• Date Received: 2005-04-07
• Date of Report: 2005-04-07
• Date of Event: 2005-02-15
• Report Date: 2005-04-07
• Date Reported to FDA: 2005-04-07
• Date Added to Maude: 2005-04-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STRYKER
• Generic Name: AMBULANCE STRETCHER
• Product Code: FPO
• Date Received: 2005-04-07
• Model Number: MX-PRO
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 580353
• Manufacturer: STRYKER MEDICAL
• Manufacturer Address: 6300 SOUTH SPRINKLE RD. KALAMAZOO MI 49001 US

Device Sequence Number: 2

• Brand Name: 20 H TRANSPORT INCUBATOR
• Generic Name: INCUBATOR
• Product Code: FPL
• Date Received: 2005-04-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 580354
• Manufacturer: AIRBORNE LIFE SUPPORT SYSTEMS, INC.
• Manufacturer Address: 8508 CROSS PARK DR. AUSTIN TX 78754 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-04-07