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

Model Number MODEL 100

Device Problems Contamination (1120); Low Battery (2584); Device Displays Incorrect Message (2591)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

Complainant alleged that when the battery status led indicator was pressed, it showed that the battery was fully charged.However, after a few compressions were performed during patient use, the platform stopped and indicated that the battery was "dead" (depleted).The battery was replaced with a new one.At the same time this incident occurred, the patient vomited.The patient's vomit got into the battery compartment and possibly contaminated it.The autopulse then displayed a "misalignment error" message, therefore use of the autopulse platform was discontinued.Customer reverted to manual cpr (length of time not provided).No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Customer reported that the battery was in the autopulse unit for 12 hours.Customer also reported that on (b)(6) 2014, an attempt was made to insert the same battery into the autopulse platform, however, the "dead battery" (depleted battery) message appeared again.Customer also specified that they had intermittently observed this during earlier shift checks, whereby the battery status led would indicate that it was fully charged, however the autopulse indicated that it was "dead" (depleted).It was also observed that the digital display was flickering and anti skid treads were coming off the platform.Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.Please see the following related mfr report: #3003793491-2014-00195 autopulse li-ion battery sn (b)(4).

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that the front enclosure was damaged and one long grip strip was missing.The physical damages found during visual inspection confirmed the reported issue of the "anti-skid treads coming off of the platform".The damages appear to have been caused by normal wear and tear (autopulse manufactured in 7/2010).A review of the archive was performed and the reported complaint of "dead" battery and misalignment error were confirmed.The archive data shows that user advisories (uas) 2 (compression tracking error), 17 (max motor on time exceeded during active operation), 12 (lifeband not present), 7 (discrepancy between load 1 and load 2 too large), and 45 (not at "home" position after power-on/restart) occurred on the reported event date of (b)(6) 2014.User advisories, 2, 7, and 45 are related to the reported complaint of "misalignment error".Ua12 and ua17 are not related to the reported complaint of "misalignment error".The reported complaint of "dead" battery was confirmed.It was observed that the error message "warning 1 - low battery warning" occurred on the reported event date with li-ion battery s/n (b)(4) (date code: 4/2013).It was also observed that this battery was properly maintained.The autopulse system labeling requires the user to "test cycle" each battery monthly.Furthermore, it was also observed that li-ion battery s/n (b)(4) (date code: 4/2013) was not properly maintained.The number of test cycles obtained for this battery was 7 cycles.If proper battery management had been followed, the expected number of test cycles would be 11 (+/-1).Not following the recommended battery maintenance may result in the battery not having sufficient capacity to operate effectively.Functional testing was performed and the reported issue that the battery was "dead" and the autopulse displayed a misalignment error were not observed during functional testing.The reported complaint of the "flickering display" was confirmed upon power up.An intermittent user advisory (ua) 12 message was also observed upon power up.It was found that the belt sense switch needed adjustment.The belt sense switch was adjusted to address the problem.Based on the investigation, the parts that were identified for replacement were the lcd, front enclosure and the grip strip.In summary, the reported complaint of "dead" battery and misalignment error were confirmed from the archive review.However they were unable to be duplicated during functional testing.The physical damages found during visual inspection confirmed the reported complaint of anti-skid treads coming off the platform.The fault was found to be due to normal wear and tear.The reported issue of "flickering display" was confirmed during functional testing.The fault was found to be due to the defective lcd.The ua12 and ua17 observed from the archive review and during functional testing are unrelated to the reported complaint.The fault for ua12 was found to be due to the looseness of the belt sense switch.The root cause for ua17 could not be determined.Per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 17 is an indication that the lifeband is twisted or battery voltage is low.The ua2, ua7, and ua45 observed from the archive review are related to the reported complaint of "misalignment error".The root cause for these user advisories could not be determined.However, per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.Per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 7 is an indication that the patient is out of position or not properly centered.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.The battery management assessment results are related to the reported complaint of the platform displaying "dead battery".Upon replacement of the damaged parts, the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3757973
• MDR Text Key: 21971464
• Report Number: 3003793491-2014-00196
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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
• Treatment: MANUAL CPR
• Patient Age: 51 YR