MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT SLEEP SURFACE; BED, PATIENT ROTATION, POWERED

Catalog Number 2950000000

Device Problems Device Alarm System (1012); Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 02/24/2016

Event Type  Injury  

Event Description

It was reported by the customer that several pressure ulcers allegedly occurred due to the mattress deflating and no alarm signaling loss of inflation.

Manufacturer Narrative

Follow-up submitted with evaluation results which determined the mattress was not inflating due to the power cord not being plugged in at time of event.Customer stated this was primarily a user error, as staff forgets to plug in the unit or only partially plugs in the unit, which results in the mattress not having power and not inflating.There is no alarm when the unit is unplugged so staff sometimes do not notice that the mattress is not working.The display board of the bed will note "mattress not detected," but this is not always checked during therapy.

Event Description

It was reported by the customer that several pressure ulcers allegedly occurred due to the mattress deflating and no alarm signaling loss of inflation.

• Brand Name: XPRT SLEEP SURFACE
• Type of Device: BED, PATIENT ROTATION, 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: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5518040
• MDR Text Key: 40928519
• Report Number: 0001831750-2016-00107
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2950000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• 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