MAUDE Adverse Event Report: GETINGE SUZHOU CO. LTD. ALPHAXCELL

Model Number ALX10

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pressure Sores (2326)

Event Date 12/17/2014

Event Type  Injury  

Event Description

It was perceived by the pt that since the latest service of the pump (on (b)(6) 2014) had lost 'power', but as no alarms went off, she didn't think there was a functional problem.It was not after she developed the first pressure ulcer, while still using the system, she realized the quality was not good.With the right weight settings, she still developed a pressure ulcer.Besides the perception that the pump was not as powerful as before, it was noticed that it made a loud noise for several minutes, from time to time (for example at start-up), which was also confirmed by the driver, while he had installed the system.The pt has now used her spare pump, and this seem to function as it should be.Pressure ulcer, stage 2 was reported.

Manufacturer Narrative

(b)(4).Although a stage ii pressure ulcer is not a serious injury as defined in 21 cfr 803.3.It may be considered a serious event for a compromised pt.Additional info will be provided upon conclusion of the investigation.

• Brand Name: ALPHAXCELL
• Manufacturer (Section D): GETINGE SUZHOU CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou ; CH
• Manufacturer (Section G): GETINGE SUZHOU CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou ; CH
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4438509
• MDR Text Key: 15972935
• Report Number: 3005619970-2015-00004
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ALX10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2015
• Distributor Facility Aware Date: 12/18/2014
• Device Age: 6 YR
• Date Report to Manufacturer: 01/16/2015
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 60