MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS EZ MAX, HOSPITAL; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801309

Device Problems Obstruction of Flow (2423); Noise, Audible (3273); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation, could not establish a relationship between the event reported and the device.Visual inspection of the returned device did not identify any issues.Rattling observed is from the pole clamp holding washers and is within specification. functional evaluation revealed there was blue battery charge indicator when ac plug was connected to the device. there was blockage alarm during run test.Further investigation revealed the device's suction pump is faulty.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, the reported file is held by the quality release team. a complaint history review found other related failures.Probable cause may be a component failure.This investigation is now complete with no further action deemed necessary at this stage. smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that the device's compressor doesn¿t sound good and rattle inside unit was noticed.After investigation it was noticed that there was blockage alarm during run test.Further investigation revealed the device's suction pump is faulty.

• Brand Name: RENASYS EZ MAX, HOSPITAL
• Type of Device: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 11634927
• MDR Text Key: 244444134
• Report Number: 8043484-2021-00787
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111154644
• UDI-Public: 4582111154644
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1