MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH CONNECT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801791
Medical Device Problem Codes	Device Alarm System (1012); Defective Alarm (1014)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has a faulty battery which it stops providing charge to the device, however the device can still be operated from the charger with ac power, besides the battery failed alarm is not shown.The device keeps working without an alarm but when the ac charger is removed the device immediately switches off as no power is present, without showing any alarm.No patient harm reported.
Additional Manufacturer Narrative
D4: part number and serial number corrected.
Additional Manufacturer Narrative
H10.H3, h6: the device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.A failed main circuit board could contribute to the battery alarm not sounding.Probable causes for the failure to charge include: the inbuilt cut out preventing the battery from charging if the device reaches a set temperature whilst in use, as denoted in the ifu, and or a failed/defective battery.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TOUCH CONNECT
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10623348
• Report Number: 8043484-2020-03110
• Device Sequence Number: 3004363
• Product Code: OMP
• UDI-Device Identifier: 05000223490782
• UDI-Public: 05000223490782
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66801791
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 01/28/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/14/2020; 01/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1