MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POSITIONPRO WITH PENDANT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number 2920100000

Device Problems Fumes or Vapors (2529); Scratched Material (3020)

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

Event Date 03/08/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that there was smoke due to exposed wires on pendant cable making contact with metal bed and arcing.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: POSITIONPRO WITH PENDANT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3718786
• MDR Text Key: 4336762
• Report Number: 0001831750-2014-02835
• Device Sequence Number: 1
• Product Code: FNM
• 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: 03/08/2014

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: 2920100000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2014
• Initial Date FDA Received: 04/01/2014
• 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