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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to zoll (b)(4) service center for evaluation.A preliminary evaluation identified a user advisory (ua) 17 (max motor on time exceeded during active operation) error message.A supplemental report will be filed when the product investigation has bee completed.Device not returned.

Event Description

It was reported that during use on a patient the device suddenly stopped.The patient was approximately (b)(6).During the event paramedics were using the lifepak 15 (manufactured by physio control) and shocked the patient with 200 j (joules) for the first shock and 360 j for the second, both while the autopulse was performing compressions.After the second shock the autopulse stopped performing compressions.After the event the autopulse platform (s/n (b)(4)) displayed user advisory 45 (not at "home" position after power-on/restart) error message.There was no status of the patient condition or additional information provided.Follow up for additional information has been performed on (b)(6) 2016.

Manufacturer Narrative

The autopulse platform (s/n (b)(4) was returned to zoll for evaluation.Investigation results as follows: device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).A visual inspection of the returned autopulse platform was performed and no physical damage noted upon receipt.A review of the platform archive log showed user advisory (ua) 17 (max motor on time exceeded) and user advisory 45 (shaft not at "home" position) messages.The archive also showed that on (b)(6) 2016, li-ion battery s/n (b)(4) with a high remain capacity (not fresh out from the charger) was used on a large size stiff to compress patient for a few minutes.The device stopped compressing due to user advisory 17 - (max motor on time exceeded).The use of the device was continued repeatedly.However, the platform stopped multiple times displaying ua17 message.The archive showed that the li-ion battery s/n (b)(4) was inside the autopulse six consecutive days without being charged or test cycled as recommended in the autopulse user guide.In addition, the archive also showed that there were multiple user advisory 45 messages that had occurred on (b)(6) 2016.The platform was functional tested and the autopulse exhibited no user advisory messages.A run in test with the 95% patient test fixture with good known batteries was performed for couple hours and the platform did not exhibit any faults or errors.A drive train motor brake gap inspection was performed and verified the gap was within the specification.The autopulse passed all the testing and met all required specifications.In summary, the customer's reported complaint of autopulse displaying an error message was confirmed during archive review but not during functional testing.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.Therefore, the exact root cause for the user advisories could not be determined.However, based on the archive log review, battery management is a probable cause for ua 17.For ua 45 the probable cause is the lifeband straps not pulled completely up prior to turning the device on thus causing the drive shaft not to be at the home position.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5457058
• MDR Text Key: 38894948
• Report Number: 3010617000-2016-00100
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

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 Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2015
• 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