MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. PDM; PHYSIOLOGICAL PATIENT MONITOR

Lot Number SA313043882GR

Device Problems Burst Container or Vessel (1074); Melted (1385); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available as the issue was identified prior to patient use.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported that the battery inside in the pdm exploded.There was no reported patient consequence as the event occurred during pre-use checkout.

Manufacturer Narrative

The pdm and battery involved were not available for ge healthcare engineering evaluation.Investigation into the event was based on the limited information and photos provided by the customer.The customer clarified that the pdm and internal battery did not explode, catch fire nor create any smoke.This is consistent with the photos of the pdm case which showed a melting and slight discoloration of the plastic housing.The investigation concluded the pdm likely overheated due to a shorting of the battery terminals due to fluid ingress.The source of the heat, as indicated by the biomedical technician, was likely the pdm battery which shorted out due to fluid entering the pdm.Conductive cleaning solutions can short out the battery terminals thus causing the battery to overheat.

• Brand Name: PDM
• Type of Device: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle el cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle el cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: david glasgow ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 6090814
• MDR Text Key: 60027326
• Report Number: 3008729547-2016-00008
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

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: Health Professional
• Device Lot Number: SA313043882GR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1