MAUDE Adverse Event Report: STRYKER MEDICAL PIONEER; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number PIONEER

Device Problems Crack (1135); Device Contamination with Body Fluid (2317)

Patient Problems Abdominal Pain (1685); Exposure to Body Fluids (1745)

Event Date 02/28/2015

Event Type  malfunction  

Event Description

Male patient was in the emergency department for abdominal pain.Physician noted patient's gown had blood soaked spot (quarter-sized).Patient assessed and noted to have no open wounds.It was determined that the mattress cover was cracked and mattress soaked with blood.Previous patient had been a vaginal hemmorrhage.
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manufacturer response for emergency room patient bed, pioneer (7 beds) (per site reporter).
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mfr inquired about cleaning methods/materials and suggested bleach was pooled on cover causing cracking and breaking of cover.

• Brand Name: PIONEER
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 4619942
• MDR Text Key: 5594610
• Report Number: 4619942
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/12/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient
• Device Model Number: PIONEER
• Device Catalogue Number: 0850-030-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 73