MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED

Catalog Number C1000DF

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 07/23/2016

Event Type  Injury  

Event Description

It was alleged that a patient managed to pull the plug from the device and disconnected the connecting plugs.A nurse intervened by removing the plug from the patient's hand and received an electric shock to the hand.The nurse went to the emergency room where they were put under surveillance.No further information regarding the severity of the alleged injury is known.

Manufacturer Narrative

This unit was returned and inspected by stryker medical.The damage to the pump was confirmed and it appeared that the cord into the compressor had been pulled out.The issue was resolved for the customer by discussing the issue with the account and confirming that nothing further was required at this time.

Event Description

It was alleged that a patient managed to pull the plug from the device and disconnected the connecting plugs.A nurse intervened by removing the plug from the patient's hand and received an electric shock to the hand.The nurse went to the emergency room where they were put under surveillance.No further information regarding the severity of the alleged injury is known.

• Brand Name: AIR EXPRESS 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5913480
• MDR Text Key: 53456669
• Report Number: 0001831750-2016-00274
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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: No Information
• Device Catalogue Number: C1000DF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2010
• 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