MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed referenced mfr reports: mfr 3010617000-2017-00599 = (b)(4) autopulse platform, mfr 3010617000-2017-00626 = (b)(4) autopulse platform, mfr 3010617000-2017-00640 = (b)(4) autopulse platform, mfr 3010617000-2017-00636 = (b)(4) li-ion battery, mfr 3010617000-2017-00620 = (b)(4) li-ion battery, mfr 3010617000-2017-00638 = (b)(4) li-ion battery, mfr 3010617000-2017-00637 = (b)(4) li-ion battery, mfr 3010617000-2017-00621 = (b)(4) li-ion battery, mfr 3010617000-2017-00639 = (b)(4) li-ion battery, mfr 3010617000-2017-00633 = (b)(4) li-ion battery, mfr 3010617000-2017-00622 = (b)(4) li-ion battery.

Event Description

The customer reported 4 separate events involving possibly three (3) autopulse platforms and eight (8) li-ion batteries.The specific autopulse platform and li-ion battery that was used at the time of the events is not known.Event 3: per patient care report, a (b)(6) male patient suffered from cardiac arrest due to drowning.Patient was unresponsive.According to the incident report, a bystander performed manual cpr for unknown length of time until ems arrived on the scene.According to the customer, the autopulse with a fully charge battery stopped compressions and shuts down after 10 minutes of active use.Customer stated that they replaced the battery and the same issue persisted.The use of the platform was discontinued and manual cpr was performed for unknown length of time until patient arrived to the hospital.Patient outcome is unknown.No other information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6779119
• MDR Text Key: 82781370
• Report Number: 3010617000-2017-00628
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• 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
• Patient Age: 36 YR